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PVC Hydrophilic Urethral Catheter

FDA UDI

Class II (US FDA UDI)

by Chengdu Daxan Innovative Medical Tech. Co., Ltd.

Identity

Trade Name
PVC Hydrophilic Urethral Catheter FDA UDI
Generic Name
Intermittent urethral drainage catheter, non-antimicrobial, single-use FDA UDI
Device Name
Man water sachet type,Catheter OD.14Fr FDA UDI
Model / Reference
H01-14MS FDA UDI
Description
Man water sachet type,Catheter OD.14Fr FDA UDI

Identifiers

Primary DI / UDI-DI
06971976787261 FDA UDI
510(k) Number
K212567 FDA UDI
FDA Product Code
EZD FDA UDI
GMDN Term
Intermittent urethral drainage catheter, non-antimicrobial, single-use 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

Yes

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: Intermittent urethral drainage catheter, non-antimicrobial, single-use

PVC Hydrophilic Urethral Catheter by Chengdu Daxan Innovative Medical Tech. Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.

Cleared under the same submission

K212567 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Chengdu Daxan Innovative Medical Tech. Co., Ltd.

Sources (1)

  • FDA UDI ec627f6e-768d-4820-b308-db9af7fc56b6 34 fields · synced May 30, 2026