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Envision Transducer Cover

FDA UDI

Class II (US FDA UDI)

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Envision Transducer Cover FDA UDI
Generic Name
Body-surface ultrasound imaging transducer cover FDA UDI
Device Name
Sterile (14x244cm) CIV-flex cover with Enviision FDA UDI
Model / Reference
H2O-018 FDA UDI
Description
Sterile (14x244cm) CIV-flex cover with Enviision FDA UDI

Identifiers

Catalog Number
H2O-018 FDA UDI
Primary DI / UDI-DI
10841436120637 FDA UDI
510(k) Number
K190802 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Body-surface ultrasound imaging transducer cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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 — 14 Centimeter FDA UDI
Width — 244 Centimeter FDA UDI

Category: Body-surface ultrasound imaging transducer cover

Envision Transducer Cover by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body-surface ultrasound imaging transducer cover.

Cleared under the same submission

K190802 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Civco Medical Instruments Co., Inc.

Sources (1)

  • FDA UDI 77bab400-e8e6-49ee-ab89-fd56a626e836 38 fields · synced Jun 8, 2026