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Necessities Kit

FDA UDI

Class II (US FDA UDI)

by Remington Medical, Inc.

Identity

Trade Name
Necessities Kit FDA UDI
Generic Name
Angiography kit FDA UDI
Device Name
Cardio Kit Containing (1) 9Fr Single Hemostasis Valve, (1) 20GAx5" Insertion Tool and (1) 0.009 - 0.018" Guidewire Torque Device FDA UDI
Model / Reference
NK-01 FDA UDI
Description
Cardio Kit Containing (1) 9Fr Single Hemostasis Valve, (1) 20GAx5" Insertion Tool and (1) 0.009 - 0.018" Guidewire Torque Device FDA UDI

Identifiers

Catalog Number
NK-01 FDA UDI
Primary DI / UDI-DI
00813079022602 FDA UDI
FDA Product Code
OEQ FDA UDI
GMDN Term
Angiography kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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

Dimensions & Sizes

Size
Catheter Gauge — 9 French FDA UDI

Category: Angiography kit

Necessities Kit by Remington Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Angiography kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Remington Medical, Inc.

Sources (1)

  • FDA UDI 691ec14d-5703-44ee-9a30-f7993b530003 36 fields · synced Jun 8, 2026