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AMSure® Sterile Water for Inhalation, USP 1000mL

FDA UDI

Class II (US FDA UDI)

by Amsino International, Inc.

Identity

Trade Name
AMSure® Sterile Water for Inhalation, USP 1000mL FDA UDI
Generic Name
Inhalation therapy sterile water FDA UDI
Device Name
AMSure® Sterile Water for Inhalation, USP 1000mL FDA UDI
Model / Reference
1 FDA UDI
Description
AMSure® Sterile Water for Inhalation, USP 1000mL FDA UDI

Identifiers

Catalog Number
AS1065 FDA UDI
Primary DI / UDI-DI
40704411010341 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Inhalation therapy sterile water FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5630 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

No

FDA UDI

Category: Inhalation therapy sterile water

AMSure® Sterile Water for Inhalation, USP 1000mL by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inhalation therapy sterile water.

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 284637e2-0f66-4c1f-864c-a4d4b1fd32f8 34 fields · synced Jun 8, 2026