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Unbranded

FDA UDI

Class II (US FDA UDI)

by Advance Medical Designs, Inc.

Identity

Trade Name
UNBRANDED FDA UDI
Generic Name
Intra-arterial needle FDA UDI
Device Name
Arterial Needle FDA UDI
Model / Reference
5005NS FDA UDI
Description
Arterial Needle FDA UDI

Identifiers

Primary DI / UDI-DI
00848340009365 FDA UDI
FDA Product Code
DRC FDA UDI
GMDN Term
Intra-arterial needle FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1390 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

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
Sterilization Method
Ethylene Oxide FDA UDI

Category: Intra-arterial needle

Unbranded by Advance Medical Designs, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intra-arterial needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advance Medical Designs, Inc.

Sources (1)

  • FDA UDI f1f15411-09c3-4879-bffd-4e697c8fb8c9 33 fields · synced Jun 8, 2026