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Covidien

FDA UDI

Class II (US FDA UDI)

by Nurse Assist, Inc.

Identity

Trade Name
COVIDIEN FDA UDI
Generic Name
Device-irrigation sterile water FDA UDI
Device Name
30ML PREFILLED SYRINGE FDA UDI
Model / Reference
6496723 FDA UDI
Description
30ML PREFILLED SYRINGE FDA UDI

Identifiers

Primary DI / UDI-DI
B15064967234 FDA UDI
510(k) Number
K030813 FDA UDI
FDA Product Code
EZL FDA UDI
GMDN Term
Device-irrigation sterile water FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 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

No

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: Device-irrigation sterile water

Covidien by Nurse Assist, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Device-irrigation sterile water.

Cleared under the same submission

K030813 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nurse Assist, Inc.

Sources (1)

  • FDA UDI c3f92b71-6e05-4536-9479-43c249f19326 34 fields · synced May 31, 2026