Nar

FDA UDI

Class I (US FDA UDI)

by North American Rescue, Llc.

Identity

Trade Name: NAR FDA UDI
Generic Name: Pneumothorax catheter insertion set FDA UDI
Device Name: NEEDLE DECOMPRESSION - ENHANCED ARS - 14G X 3.25" FDA UDI
Model / Reference: 10-0063 FDA UDI
Description: NEEDLE DECOMPRESSION - ENHANCED ARS - 14G X 3.25" FDA UDI

Identifiers

Primary DI / UDI-DI: 00842209125852 FDA UDI
FDA Product Code: GAA FDA UDI
GMDN Term: Pneumothorax catheter insertion set FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 14 Gauge FDA UDI

Category: Pneumothorax catheter insertion set

Nar by North American Rescue, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: North American Rescue, Llc.

Sources (1)

FDA UDI 758675c3-8578-4e59-9e6d-b25c589794f0 34 fields · synced May 30, 2026