Vacuum Collection Bottle

FDA UDI

Class I (US FDA UDI)

by Hangzhou A-Tek Medical & Textiles Co., Ltd.

Identity

Trade Name: VACUUM COLLECTION BOTTLE FDA UDI
Generic Name: Surgical tissue/fluid collection bag FDA UDI
Device Name: VACUUM COLLECTION BOTTLE, COLLECT LARGER VOLUMES OF FLUID FROM PROCEDURES FDA UDI
Model / Reference: 28031 FDA UDI
Description: VACUUM COLLECTION BOTTLE, COLLECT LARGER VOLUMES OF FLUID FROM PROCEDURES FDA UDI

Identifiers

Primary DI / UDI-DI: 06950471300144 FDA UDI
FDA Product Code: KDG FDA UDI
GMDN Term: Surgical tissue/fluid collection bag FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical tissue/fluid collection bag

Vacuum Collection Bottle by Hangzhou A-Tek Medical & Textiles Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Hangzhou A-Tek Medical & Textiles Co., Ltd.

Sources (1)

FDA UDI c8bf5a76-f5dd-4cff-8c69-aa9ad2189c98 33 fields · synced Jun 1, 2026