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AMSafe ® Pre-Filled Normal Saline Flush Syringe

FDA UDI

Class II (US FDA UDI)

by Amsino International, Inc.

Identity

Trade Name
AMSafe ® Pre-Filled Normal Saline Flush Syringe FDA UDI
Generic Name
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial FDA UDI
Device Name
Pre-Filled Normal Saline Flush Syringe, 10 ml 0.9% Sodium Chloride Injection, USP, dust cover package, Sterile Fluid Path, Gamma radiation sterilization FDA UDI
Model / Reference
1 FDA UDI
Description
Pre-Filled Normal Saline Flush Syringe, 10 ml 0.9% Sodium Chloride Injection, USP, dust cover package, Sterile Fluid Path, Gamma radiation sterilization FDA UDI

Identifiers

Catalog Number
IVF1010 FDA UDI
Primary DI / UDI-DI
30704411013499 FDA UDI
510(k) Number
K183473 FDA UDI
FDA Product Code
NGT FDA UDI
GMDN Term
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5200 FDA UDI
Commercial Distribution
Not 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

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

AMSafe ® Pre-Filled Normal Saline Flush Syringe by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K183473 also covers:

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 1c4708bc-dbb0-437e-be51-f80ef17dbcfd 36 fields · synced Jun 8, 2026