Normal Saline IV Flush Syringe

FDA UDI

Class II (US FDA UDI)

by Medefil, Inc.

Identity

Trade Name: Normal Saline IV Flush Syringe FDA UDI
Generic Name: Vascular catheter flush syringe FDA UDI
Device Name: Medefil Normal Saline IV Flush Syringe, 10mL fill in 12mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use FDA UDI
Model / Reference: 10mL in 12mL syringe FDA UDI
Description: Medefil Normal Saline IV Flush Syringe, 10mL fill in 12mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use FDA UDI

Identifiers

Catalog Number: MIS-1130 FDA UDI
Primary DI / UDI-DI: 30364253111304 FDA UDI
510(k) Number: K091583 FDA UDI
FDA Product Code: NGT FDA UDI
GMDN Term: Vascular catheter flush syringe FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vascular catheter flush syringe

Normal Saline IV Flush Syringe by Medefil, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medefil, Inc.

Sources (1)

FDA UDI 365914fe-24bb-4de7-a774-454e102e20c4 37 fields · synced May 30, 2026