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AMSure® Specimen Container

FDA UDI

Class I (US FDA UDI)

by Amsino International, Inc.

Identity

Trade Name
AMSure® Specimen Container FDA UDI
Generic Name
Sputum specimen container IVD FDA UDI
Device Name
AMSure® Specimen Container Non-Toxic 4 oz./120cc CAUTION:Avoid freezing and excessive heat. FDA UDI
Model / Reference
1 FDA UDI
Description
AMSure® Specimen Container Non-Toxic 4 oz./120cc CAUTION:Avoid freezing and excessive heat. FDA UDI

Identifiers

Catalog Number
AS340 FDA UDI
Primary DI / UDI-DI
10704411010012 FDA UDI
FDA Product Code
FMH FDA UDI
GMDN Term
Sputum specimen container IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 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

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: Sputum specimen container IVD

AMSure® Specimen Container by Amsino International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sputum specimen container IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amsino International, Inc.

Sources (1)

  • FDA UDI d252339a-f765-4db7-ba82-136ecce19ba1 34 fields · synced May 30, 2026