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AMSure®Sterile Water for Wound Flush

FDA UDIEUDAMED

Class U (US FDA UDI)

Ref AS399K-1Ref AS399KRef AS399-1

by Amsino International, Inc.

Identity

Trade Name
AMSure® Sterile Water EUDAMED
AMSure®Sterile Water for Wound Flush FDA UDI
AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL FDA UDI
Generic Name
Wound irrigation sterile saline FDA UDI
Inhalation therapy sterile water FDA UDI
Device Name
Sterile Water, and Sterile Normal Saline for Wound Flush EUDAMED
AMSure® Sterile Water for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water for wound flush are intended to be used in home care and should only be used by clinicians familiar with the treatment of possible complications. FDA UDI
AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL FDA UDI
Model / Reference
AS399K-1 EUDAMED
AS399K EUDAMED
AS399-1 EUDAMED
1 FDA UDI
Description
AMSure® Sterile Water for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water for wound flush are intended to be used in home care and should only be used by clinicians familiar with the treatment of possible complications. FDA UDI
AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL FDA UDI

Identifiers

Catalog Number
AS399-1 FDA UDI
AS0552 FDA UDI
Primary DI / UDI-DI
00704411010367 EUDAMEDFDA UDI
00704411018950 EUDAMED
00704411018943 EUDAMED
40704411010334 FDA UDI
Basic UDI-DI
B-00704411018950 EUDAMED
B-00704411018943 EUDAMED
B-00704411010367 EUDAMED
510(k) Number
K181423 FDA UDI
FDA Product Code
FRO FDA UDI
BTT FDA UDI
EMDN Code
M04040101 SALINE DRESSINGS, NON-COMBINED EUDAMED
GMDN Term
Wound irrigation sterile saline FDA UDI
Inhalation therapy sterile water FDA UDI

Classification

Device Class
Class IIa EUDAMED
U FDA UDI
Class II FDA UDI
Regulation Number
868.5450 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDIFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDIFDA 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: Wound irrigation sterile saline

AMSure®Sterile Water for Wound Flush by Amsino International, Inc. — Class U — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Wound irrigation sterile saline.

Cleared under the same submission

K181423 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amsino International, Inc.

Sources (5)

  • FDA UDI ffca8f7c-fa87-4d97-9e25-8848d89e0993 35 fields · synced Jul 26, 2026
  • FDA UDI b8033f46-131e-44ea-a3ae-e0424b44e7d6 34 fields · synced May 30, 2026
  • EUDAMED d632ea4e-08f4-4689-a9c5-2a82efb2b0f2 61 fields · synced Jul 19, 2026
  • EUDAMED c87b2dcf-b46c-4314-9ed6-dc558bc43d09 61 fields · synced Jul 23, 2026
  • EUDAMED 8205a40d-34f1-4f27-b3d1-58809398c1e3 61 fields · synced Jul 26, 2026