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Medrad® Pres

FDA UDI

Class I (US FDA UDI)

by Bayer Medical Care Inc.

Identity

Trade Name
MEDRAD® PRES FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
CT Pressure Rated Extension Set - 50 (CT - EXTENSION SET,QWIKSTRIPS, BOX OF 50) (83920742) FDA UDI
Model / Reference
PRES50 FDA UDI
Description
CT Pressure Rated Extension Set - 50 (CT - EXTENSION SET,QWIKSTRIPS, BOX OF 50) (83920742) FDA UDI

Identifiers

Catalog Number
PRES50 FDA UDI
Primary DI / UDI-DI
00616258005416 FDA UDI
FDA Product Code
KGZ FDA UDI
GMDN Term
Intravenous administration tubing extension set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 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

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

Yes

FDA UDI

Category: Intravenous administration tubing extension set

Medrad® Pres by Bayer Medical Care Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous administration tubing extension set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 34c68f30-de78-45fd-98cc-cee8f88eeb3b 35 fields · synced Jun 9, 2026