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Guerbet Ext/Inj line Straight CT/MR

FDA UDI

Class II (US FDA UDI)

by Cair Lgl

Identity

Trade Name
Guerbet Ext/Inj line Straight CT/MR FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
150 cm Straight Extension/Injection Line for CT & MRI FDA UDI
Model / Reference
PN-MDX3515M FDA UDI
Description
150 cm Straight Extension/Injection Line for CT & MRI FDA UDI

Identifiers

Catalog Number
240004 FDA UDI
Primary DI / UDI-DI
13661657031058 FDA UDI
510(k) Number
K171118 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Intravenous administration tubing extension set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

No

FDA UDI

Category: Intravenous administration tubing extension set

Guerbet Ext/Inj line Straight CT/MR by Cair Lgl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous administration tubing extension set.

Cleared under the same submission

K171118 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cair Lgl

Sources (1)

  • FDA UDI ab063b61-f9a9-403a-afbf-eda14dfd82fd 35 fields · synced Jun 6, 2026