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Pending

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
PENDING FDA UDI
Generic Name
Vascular access device flush/disinfection tool FDA UDI
Device Name
SYRINGE, SWABFLUSH,10/10ML, W/SWABCAP FDA UDI
Model / Reference
EMZE010301 FDA UDI
Description
SYRINGE, SWABFLUSH,10/10ML, W/SWABCAP FDA UDI

Identifiers

Catalog Number
EMZE010301 FDA UDI
Primary DI / UDI-DI
10888277675865 FDA UDI
510(k) Number
K130975 FDA UDI
FDA Product Code
NGT FDA UDI
GMDN Term
Vascular access device flush/disinfection tool 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

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

Category: Vascular access device flush/disinfection tool

Pending by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular access device flush/disinfection tool.

Cleared under the same submission

K130975 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI 2feadd10-4989-4fbd-983e-b5c594c767f3 36 fields · synced May 30, 2026