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CIV-Flex™ Transducer Cover

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 610-006Ref 610-1121Ref 610-1212Ref 610-1304Ref 610-002Ref 610-903Ref 610-1309Ref 610-999Ref 610-1229Ref 610-2327Ref 610-1120Ref UA0009Ref 610-1013Ref 610-637Ref UA0008Ref 610-1010Ref 610-001Ref 610-973Ref 610-860Ref 610-005Ref 610-542TRRef 610-1064Ref 610-575; 610-575BRef 610-362Ref UA0070Ref 610-1119

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
CIV-Flex™ Transducer Cover EUDAMEDFDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Body-orifice ultrasound imaging transducer cover, basic FDA UDI
Intraoperative ultrasound imaging transducer cover FDA UDI
Device Name
Intracavity Covers (CIV-Flex sterile) EUDAMED
General Purpose and Intraoperative Covers (CIV-Flex sterile) EUDAMED
General Purpose and Intraoperative Covers (CIV-Flex non-sterile) EUDAMED
Intracavity Covers (TEE CIV-Flex non-sterile) EUDAMED
Intracavity Covers (TEE CIV-Flex sterile) EUDAMED
Sterile (11.9 tapered to 3.8 x 91.5 cm) telescopically-folded cover FDA UDI
Sterile (14 x 147cm) telescopically-folded cover FDA UDI
Sterile (11.9 tapered to 3.8 x 61cm) flat-folded cover for use with BK Medical 8544, 8554, 8557, 8558, 8644, 8657, 8658, 8667, 8808, 8808e, 8809, 8815, 8818, 8819, 8824, 8848, E10C4, E14C4, E14C4t, and E14CL4b transducers FDA UDI
Sterile (14 x 244cm) telescopically-folded cover FDA UDI
Non-sterile (3.8 tapered to 1.7 x 122cm) pediatric TEE cover on applicator FDA UDI
Sterile (8.9 x 61cm) cover for use with BK Medical 6C2, 6C2s, 9C2, 14L3, 18L5, 8670, 8802, 8814, 8816, 8820e, 8823, 8830 and 8870 transducers FDA UDI
Sterile (10.2 x 244cm) telescopically-folded cover FDA UDI
Sterile (17.8 x 244cm) telescopically-folded cover FDA UDI
Non-sterile (14 x 30cm) cover FDA UDI
Non-sterile (4.6 tapered to 2.5 x 122cm) TEE cover on applicator FDA UDI
Sterile (14 x 29.2cm) telescopically-folded wireless transducer cover FDA UDI
Non-sterile (14 x 61cm) cover FDA UDI
Sterile (8.9 x 91.5cm) telescopically-folded cover FDA UDI
Non-sterile (17.8 x 147cm) telescopically-folded cover FDA UDI
14 x 91.5cm telescopically-folded cover FDA UDI
Sterile (3.8 tapered to 1.7 x 122cm) TEE cover on applicator FDA UDI
Sterile (14 x 61cm) flat-folded cover FDA UDI
CIV-Flex Transducer Cover (14 x 147cm) - Qty: 5. FUJIFILM SonoSite, Inc L25 Needle Guide (18GA) - Qty: 5. FUJIFILM SonoSite, Inc. L25 Needle Guide (21GA) - Qty: 5. Infiniti Plus Needle Guide (18-25GA) - Qty: 5. Infiniti SnapFIT Transducer Cover - Qty: 5. FDA UDI
Sterile (14 x 91.5cm) telescopically-folded cover for use with BK Medical 6C2, 10L2w, 13L4w, 8801, 8811, 8820e, 8822 and 8830 transducers FDA UDI
Sterile (11.9 tapered to 3.8 x 61cm) flat-folded cover FDA UDI
Sterile (10.2 x 147cm) telescopically-folded cover FDA UDI
Sterile (8.9 x 61cm) flat-folded cover FDA UDI
Sterile (17.8 x 147cm) telescopically-folded cover FDA UDI
Sterile (22.9 x 61cm) flat-folded cover FDA UDI
Non-sterile (6x91.5cm) flat folded cover FDA UDI
Model / Reference
610-999 EUDAMEDFDA UDI
610-1304 EUDAMEDFDA UDI
UA0008 EUDAMEDFDA UDI
610-1229 EUDAMEDFDA UDI
UA0009 EUDAMEDFDA UDI
610-1119 EUDAMEDFDA UDI
610-1121 EUDAMEDFDA UDI
610-903 EUDAMEDFDA UDI
610-860 EUDAMEDFDA UDI
610-362 EUDAMEDFDA UDI
610-1309 EUDAMEDFDA UDI
610-542TR EUDAMEDFDA UDI
610-1013 EUDAMEDFDA UDI
610-002 EUDAMEDFDA UDI
610-973 EUDAMEDFDA UDI
UA0070 EUDAMEDFDA UDI
610-1064 EUDAMEDFDA UDI
610-001 EUDAMEDFDA UDI
610-1010 EUDAMEDFDA UDI
610-005 EUDAMEDFDA UDI
610-2327 EUDAMEDFDA UDI
610-006 EUDAMED
610-1212 EUDAMED
610-1120 EUDAMED
610-637 EUDAMED
610-575; 610-575B EUDAMED
610-1120, 610-1120-5 FDA UDI
610-575, 610-575-5, 610-575B FDA UDI
610-1212, 610-1212-5 FDA UDI
610-637, 610-637-5 FDA UDI
610-006, 610-006-5 FDA UDI
Description
Sterile (11.9 tapered to 3.8 x 91.5 cm) telescopically-folded cover FDA UDI
Sterile (14 x 147cm) telescopically-folded cover FDA UDI
Sterile (11.9 tapered to 3.8 x 61cm) flat-folded cover for use with BK Medical 8544, 8554, 8557, 8558, 8644, 8657, 8658, 8667, 8808, 8808e, 8809, 8815, 8818, 8819, 8824, 8848, E10C4, E14C4, E14C4t, and E14CL4b transducers FDA UDI
Sterile (14 x 244cm) telescopically-folded cover FDA UDI
Non-sterile (3.8 tapered to 1.7 x 122cm) pediatric TEE cover on applicator FDA UDI
Sterile (8.9 x 61cm) cover for use with BK Medical 6C2, 6C2s, 9C2, 14L3, 18L5, 8670, 8802, 8814, 8816, 8820e, 8823, 8830 and 8870 transducers FDA UDI
Sterile (10.2 x 244cm) telescopically-folded cover FDA UDI
Sterile (17.8 x 244cm) telescopically-folded cover FDA UDI
Non-sterile (14 x 30cm) cover FDA UDI
Non-sterile (4.6 tapered to 2.5 x 122cm) TEE cover on applicator FDA UDI
Sterile (14 x 29.2cm) telescopically-folded wireless transducer cover FDA UDI
Non-sterile (14 x 61cm) cover FDA UDI
Sterile (8.9 x 91.5cm) telescopically-folded cover FDA UDI
Non-sterile (17.8 x 147cm) telescopically-folded cover FDA UDI
14 x 91.5cm telescopically-folded cover FDA UDI
Sterile (3.8 tapered to 1.7 x 122cm) TEE cover on applicator FDA UDI
Sterile (14 x 61cm) flat-folded cover FDA UDI
CIV-Flex Transducer Cover (14 x 147cm) - Qty: 5. FUJIFILM SonoSite, Inc L25 Needle Guide (18GA) - Qty: 5. FUJIFILM SonoSite, Inc. L25 Needle Guide (21GA) - Qty: 5. Infiniti Plus Needle Guide (18-25GA) - Qty: 5. Infiniti SnapFIT Transducer Cover - Qty: 5. FDA UDI
Sterile (14 x 91.5cm) telescopically-folded cover for use with BK Medical 6C2, 10L2w, 13L4w, 8801, 8811, 8820e, 8822 and 8830 transducers FDA UDI
Sterile (11.9 tapered to 3.8 x 61cm) flat-folded cover FDA UDI
Sterile (10.2 x 147cm) telescopically-folded cover FDA UDI
Sterile (8.9 x 61cm) flat-folded cover FDA UDI
Sterile (17.8 x 147cm) telescopically-folded cover FDA UDI
Sterile (22.9 x 61cm) flat-folded cover FDA UDI
Non-sterile (6x91.5cm) flat folded cover FDA UDI

Identifiers

Catalog Number
610-999 FDA UDI
610-1304 FDA UDI
UA0008 FDA UDI
610-1120, 610-1120-5 FDA UDI
610-1229 FDA UDI
UA0009 FDA UDI
610-1119 FDA UDI
610-1121 FDA UDI
610-903 FDA UDI
610-860 FDA UDI
610-575, 610-575-5, 610-575B FDA UDI
610-1212, 610-1212-5 FDA UDI
610-362 FDA UDI
610-637, 610-637-5 FDA UDI
610-1309 FDA UDI
610-542TR FDA UDI
610-1013 FDA UDI
610-002 FDA UDI
610-973 FDA UDI
UA0070 FDA UDI
610-006, 610-006-5 FDA UDI
610-1064 FDA UDI
610-001 FDA UDI
610-1010 FDA UDI
610-005 FDA UDI
610-2327 FDA UDI
Primary DI / UDI-DI
10841436104743 EUDAMEDFDA UDI
10841436103104 EUDAMEDFDA UDI
10841436110218 EUDAMEDFDA UDI
10841436102114 EUDAMEDFDA UDI
10841436102657 EUDAMEDFDA UDI
10841436110225 EUDAMEDFDA UDI
10841436102091 EUDAMEDFDA UDI
10841436102121 EUDAMEDFDA UDI
00841436104333 EUDAMEDFDA UDI
10841436104286 EUDAMEDFDA UDI
10841436103777 EUDAMEDFDA UDI
10841436102411 EUDAMEDFDA UDI
00841436103695 EUDAMEDFDA UDI
10841436103920 EUDAMEDFDA UDI
00841436103145 EUDAMEDFDA UDI
10841436119907 EUDAMEDFDA UDI
10841436101629 EUDAMEDFDA UDI
10841436101278 EUDAMEDFDA UDI
00841436104630 EUDAMEDFDA UDI
10841436110324 EUDAMEDFDA UDI
10841436101315 EUDAMEDFDA UDI
10841436101896 EUDAMEDFDA UDI
10841436101261 EUDAMEDFDA UDI
10841436101599 EUDAMEDFDA UDI
10841436101292 EUDAMEDFDA UDI
00841436118590 EUDAMEDFDA UDI
Basic UDI-DI
0841436101TD201C1NQ EUDAMED
0841436101TD201A1NJ EUDAMED
0841436101TD201A8NY EUDAMED
0841436101TD201C7P4 EUDAMED
0841436101TD201C8P6 EUDAMED
Unit of Use DI
80841436104339 EUDAMED
80841436103141 EUDAMED
80841436118596 EUDAMED
80841436104636 EUDAMED
80841436103691 EUDAMED
510(k) Number
K970513 FDA UDI
FDA Product Code
ITX FDA UDI
EMDN Code
T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
GMDN Term
Body-surface ultrasound imaging transducer cover FDA UDI
Body-orifice ultrasound imaging transducer cover, basic FDA UDI
Intraoperative ultrasound imaging transducer cover FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Length — 91.5 Centimeter FDA UDI
Width — 11.9 Centimeter FDA UDI
Width — 14 Centimeter FDA UDI
Length — 147 Centimeter FDA UDI
Width — 3.8 Centimeter FDA UDI
Length — 61 Centimeter FDA UDI
Length — 244 Centimeter FDA UDI
Width — 1.5 Inch FDA UDI
Length — 3.5 Inch FDA UDI
Width — 8.9 Centimeter FDA UDI
Width — 10.2 Centimeter FDA UDI
Width — 17.8 Centimeter FDA UDI
Length — 12 Inch FDA UDI
Width — 5.5 Inch FDA UDI
Length — 4.25 Inch FDA UDI
Length — 58 Inch FDA UDI
Length — 30 Centimeter FDA UDI
Length — 24 Inch FDA UDI
Width — 7 Inch FDA UDI
Length — 5.5 Inch FDA UDI
Width — 36 Inch FDA UDI
Length — 91 Centimeter FDA UDI
Width — 4.7 Inch FDA UDI
Width — 5 Inch FDA UDI
Width — 3.5 Inch FDA UDI
Width — 9 Inch FDA UDI

Category: Body-surface ultrasound imaging transducer cover

CIV-Flex™ Transducer Cover by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Body-surface ultrasound imaging transducer cover.

Cleared under the same submission

K970513 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Civco Medical Instruments Co., Inc.

Sources (53)

  • FDA UDI 46f54208-7f05-42b7-8df7-2224abdc35c6 38 fields · synced Sep 18, 2026
  • FDA UDI caeece85-8544-41f9-9f16-36c4e1dd2a3b 38 fields · synced May 25, 2026
  • FDA UDI 8133b9fb-1716-4299-8b09-bfdb7ef13dd1 38 fields · synced May 27, 2026
  • FDA UDI f6a5aa07-a46d-4256-b3f6-dca2e53e1f82 38 fields · synced May 29, 2026
  • FDA UDI 514770d0-4c0e-4d5e-8836-c86471b24db7 38 fields · synced May 29, 2026
  • FDA UDI 295c020b-d3ec-4fc3-8d58-420424c4406f 38 fields · synced May 29, 2026
  • FDA UDI c7121346-7661-40c3-a90f-0b37cff282be 38 fields · synced May 29, 2026
  • FDA UDI b9656fb0-09ac-4d00-8bfc-6867597bd23d 38 fields · synced May 30, 2026
  • FDA UDI 7a4e35df-4043-416a-9815-7954b9e3a844 38 fields · synced May 30, 2026
  • FDA UDI f4b6bd8f-0311-4e61-b833-d2de005bb976 38 fields · synced May 30, 2026
  • FDA UDI d10198d9-af9e-4f09-8665-9e3b4297e0fa 38 fields · synced May 30, 2026
  • FDA UDI 1f66a828-308f-4e44-83ae-53b2b5ce85aa 38 fields · synced May 30, 2026
  • FDA UDI 997caa48-c5be-48c8-b252-ca0bd99a396d 38 fields · synced May 30, 2026
  • FDA UDI 7a93b683-6097-44d2-abdf-ce09cd349b67 38 fields · synced May 30, 2026
  • FDA UDI a93f56f0-e2a8-4662-b643-1e4febc8d4ff 38 fields · synced May 30, 2026
  • FDA UDI 582a284e-3336-458b-a76d-22baf72ab757 38 fields · synced May 30, 2026
  • FDA UDI 7fa20fff-96d7-4782-901e-347f74699a3a 38 fields · synced May 30, 2026
  • FDA UDI 875e2b90-d69b-4d18-a85c-894cbc9f05c9 38 fields · synced May 30, 2026
  • FDA UDI fb3e44c6-871c-4e54-8a5d-472a1524c82f 37 fields · synced May 30, 2026
  • FDA UDI 00d1a532-0f92-4cd2-9d99-0384269a96a6 38 fields · synced May 30, 2026
  • FDA UDI d1f971b6-57c8-4b25-8212-49ed2fd1ee88 38 fields · synced May 30, 2026
  • FDA UDI 6a97ed60-debe-4bed-8593-2a424d64ea21 38 fields · synced May 30, 2026
  • FDA UDI 322434da-2070-4c82-93ed-09eed49ec558 38 fields · synced May 30, 2026
  • FDA UDI b06a041a-1ee7-42e6-87b3-92fe42a69f25 38 fields · synced May 30, 2026
  • FDA UDI 41877e94-ce9e-4f88-b764-4c9eb1a9a8ed 38 fields · synced May 30, 2026
  • FDA UDI 5c52a732-9088-4e20-aeef-5434a6e636c1 37 fields · synced May 30, 2026
  • EUDAMED 68b480d5-4943-4764-b110-44ba1470bd28 61 fields · synced Jul 8, 2026
  • EUDAMED b935ff51-6bee-4479-96ca-1e2984e085b9 61 fields · synced Jul 9, 2026
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  • EUDAMED 5a4ecc37-c113-4a6b-9df8-47a5a23d01be 61 fields · synced Jul 11, 2026
  • EUDAMED 7644e3a9-6792-4e62-ab71-ac57bcdc3907 61 fields · synced Jul 11, 2026
  • EUDAMED b98d72c5-7654-4cd8-a4e0-93aebd7f9345 61 fields · synced Jul 12, 2026
  • EUDAMED 36f8ea87-2aaa-42e2-9de0-b903914606ca 61 fields · synced Jul 15, 2026
  • EUDAMED b1b4cfe0-a980-4d55-937d-d0d5408bd478 61 fields · synced Jul 15, 2026
  • EUDAMED 8c346260-093f-43f6-8c09-f1c166ff6a44 61 fields · synced Jul 16, 2026
  • EUDAMED 58b390e7-6407-4fdb-b3a8-1ced71bf33e9 61 fields · synced Jul 21, 2026
  • EUDAMED a681f428-a645-481c-ad47-a5b171035cf3 61 fields · synced Jul 22, 2026
  • EUDAMED d29cf273-f750-41f1-b4f1-bae981432c8a 61 fields · synced Jul 23, 2026
  • EUDAMED 08e98a19-1bf1-40c1-9bb3-7c6616a1245a 61 fields · synced Jul 23, 2026
  • EUDAMED 7d103e95-28c8-4f8b-83bc-cdb5c6df96a4 61 fields · synced Jul 24, 2026
  • EUDAMED 22d5cc07-c8f5-4b18-804d-f2fcd6aa27ed 61 fields · synced Jul 25, 2026
  • EUDAMED 430439ca-5953-42f2-9acb-77cf92bd4578 61 fields · synced Jul 26, 2026
  • EUDAMED f620e7a0-d792-4a0d-a855-4f8a41b5ac3c 61 fields · synced Jul 27, 2026
  • EUDAMED f3a80ae2-ef2f-4ac2-ab1b-980dadeeb62f 61 fields · synced Jul 27, 2026
  • EUDAMED c10e7534-8bc9-4909-aba3-f58fc7d061d5 61 fields · synced Jul 30, 2026
  • EUDAMED 8b0ec0fa-fb69-43ae-a5fb-e2efbc7151ca 61 fields · synced Aug 1, 2026
  • EUDAMED dbb21aba-055c-4996-bc60-723db5c01695-1 61 fields · synced Aug 3, 2026
  • EUDAMED dbb21aba-055c-4996-bc60-723db5c01695-2 61 fields · synced Aug 3, 2026
  • EUDAMED f746fe93-a567-4f62-80be-35726c37bf02 61 fields · synced Aug 4, 2026
  • EUDAMED 1030e123-a468-4469-9faa-9ae6553a899e 61 fields · synced Aug 4, 2026
  • EUDAMED ca191dbb-4af0-4e1f-945d-4cbc7ac5d189 61 fields · synced Sep 18, 2026