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American Hospital Supply

FDA UDI

Class II (US FDA UDI)

by American Hospital Supply

Identity

Trade Name
American Hospital Supply FDA UDI
Generic Name
Sterilization container liner FDA UDI
Device Name
AHS Sterilization Pouch, 5.5''x10'', 1 Each FDA UDI
Model / Reference
AHS-SP-5510_EA FDA UDI
Description
AHS Sterilization Pouch, 5.5''x10'', 1 Each FDA UDI

Identifiers

Catalog Number
AHS-SP-5510_EA FDA UDI
Primary DI / UDI-DI
00850037921737 FDA UDI
510(k) Number
K153540 FDA UDI
FDA Product Code
FRG FDA UDI
GMDN Term
Sterilization container liner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 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

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: Sterilization container liner

American Hospital Supply by American Hospital Supply — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sterilization container liner.

Cleared under the same submission

K153540 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Hospital Supply

Sources (1)

  • FDA UDI d2989789-a66a-4132-bc1e-83f205bd11aa 36 fields · synced May 31, 2026