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Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 4890-8220Ref 4890-8214Ref 4890-8212Ref 4890-8216Ref 4890-8218

by Fortune Medical Instrument Corp.

Identity

Trade Name
Silicone Supra-Pubic Catheter Exchange Set EUDAMED
Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) FDA UDI
Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) FDA UDI
Generic Name
Suprapubic drainage catheter FDA UDI
Device Name
Silicone Supra-Pubic Catheter Exchange Set EUDAMED
Model / Reference
4890-8220 EUDAMEDFDA UDI
4890-8214 EUDAMEDFDA UDI
4890-8218 EUDAMEDFDA UDI
4890-8212 EUDAMEDFDA UDI
4890-8216 EUDAMED
1890-8216 FDA UDI

Identifiers

Primary DI / UDI-DI
04710961937654 EUDAMEDFDA UDI
04710961937623 EUDAMEDFDA UDI
04710961937647 EUDAMEDFDA UDI
04710961937616 EUDAMEDFDA UDI
14710961937613 EUDAMED
14710961937637 EUDAMED
14710961937620 EUDAMED
14710961937644 EUDAMED
04710961934219 FDA UDI
Basic UDI-DI
B-04710961937654 EUDAMED
B-04710961937623 EUDAMED
B-14710961937613 EUDAMED
B-04710961937616 EUDAMED
B-14710961937637 EUDAMED
B-04710961937647 EUDAMED
B-14710961937620 EUDAMED
B-14710961937644 EUDAMED
510(k) Number
K014002 FDA UDI
FDA Product Code
KOB FDA UDI
EMDN Code
U040102 KITS WITH DRAINAGE CATHETERS AND INTRODUCERS EUDAMED
GMDN Term
Suprapubic drainage catheter FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
876.5090 FDA UDI
Market of Registration
Belgium EUDAMED
Finland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Category: Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) by Fortune Medical Instrument Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Suprapubic drainage catheter.

Cleared under the same submission

K014002 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Fortune Medical Instrument Corp.

Sources (13)

  • FDA UDI e6f08462-5dfa-4272-be56-b7e52b5ada53 33 fields · synced Oct 6, 2026
  • FDA UDI b5e64949-e01f-4ae3-9f03-c20bd3568088 33 fields · synced May 30, 2026
  • FDA UDI d162c66a-eccd-4773-9da7-561fec6971b6 33 fields · synced May 30, 2026
  • FDA UDI 6789c1e4-db63-4933-aa31-73117f91442d 33 fields · synced May 30, 2026
  • FDA UDI d05396c1-20d2-4698-8314-3705f67474a9 33 fields · synced May 30, 2026
  • EUDAMED b36e6654-ce60-4d74-a541-41bcd5f1c521 61 fields · synced Jul 10, 2026
  • EUDAMED a26d584e-db1c-481c-b88d-9e94bd8d2f06 61 fields · synced Jul 12, 2026
  • EUDAMED c3024e80-6529-45b0-ab61-6e520d2915df 61 fields · synced Jul 13, 2026
  • EUDAMED 93686571-664f-4676-9310-d657734681a0 61 fields · synced Jul 15, 2026
  • EUDAMED c1f86ca7-f177-4e01-a729-27ad23bcdf1b 61 fields · synced Jul 17, 2026
  • EUDAMED f224537d-2726-4a10-901d-d0d0f7d671bb 61 fields · synced Jul 21, 2026
  • EUDAMED fbb57dcd-c303-4dbc-aa4a-82864b84fbbd 61 fields · synced Aug 4, 2026
  • EUDAMED 58309b36-3640-4ef2-8827-f1441d7f3a34 61 fields · synced Sep 18, 2026