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Inrad

FDA UDI

Class II (US FDA UDI)

by Inrad

Identity

Trade Name
Inrad FDA UDI
Generic Name
Non-vascular catheter introduction set FDA UDI
Device Name
Modified Cournand Needle, 19 ga, 2 1/8" FDA UDI
Model / Reference
50019 FDA UDI
Description
Modified Cournand Needle, 19 ga, 2 1/8" FDA UDI

Identifiers

Primary DI / UDI-DI
00817295020602 FDA UDI
510(k) Number
K812973 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Non-vascular catheter introduction set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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: Non-vascular catheter introduction set

Inrad by Inrad — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-vascular catheter introduction set.

Cleared under the same submission

K812973 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inrad

Sources (1)

  • FDA UDI ab6cdc12-0b64-4b62-885f-41164d1197e3 35 fields · synced Jun 8, 2026