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Female Plain Intermittent Catheter Straight Tip 8ch

FDA UDI

Class II (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name
FEMALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 8CH FDA UDI
Generic Name
Urine-sampling urethral catheter FDA UDI
Model / Reference
03-51008U FDA UDI

Identifiers

Primary DI / UDI-DI
05055788710585 FDA UDI
510(k) Number
K132619 FDA UDI
FDA Product Code
KOD FDA UDI
GMDN Term
Urine-sampling urethral catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 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

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

No

FDA UDI

Category: Urine-sampling urethral catheter

Female Plain Intermittent Catheter Straight Tip 8ch by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine-sampling urethral catheter.

Cleared under the same submission

K132619 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flexicare Medical Limited

Sources (1)

  • FDA UDI 044782e9-180d-47e8-a6c9-cc42726a2012 33 fields · synced Jun 6, 2026