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Bynex

FDA UDI

Class I (US FDA UDI)

by Zhende Medical Co., Ltd.

Identity

Trade Name
Bynex FDA UDI
Generic Name
Intestinal ostomy bag/support kit FDA UDI
Device Name
Two-piece Ostomy open bag FDA UDI
Model / Reference
NZ2151V1001-1 FDA UDI
Description
Two-piece Ostomy open bag FDA UDI

Identifiers

Primary DI / UDI-DI
06926515406400 FDA UDI
FDA Product Code
PQE FDA UDI
GMDN Term
Intestinal ostomy bag/support kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intestinal ostomy bag/support kit

Bynex by Zhende Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intestinal ostomy bag/support kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zhende Medical Co., Ltd.

Sources (1)

  • FDA UDI ea120834-351a-4370-bca0-3ba7601cd21c 33 fields · synced May 30, 2026