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Argyle

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Argyle FDA UDI
Generic Name
Armboard, reusable FDA UDI
Device Name
Hydrogel Temperature Probe Cover,Rectangular FDA UDI
Model / Reference
MI30002 FDA UDI
Description
Hydrogel Temperature Probe Cover,Rectangular FDA UDI

Identifiers

Catalog Number
MI30002 FDA UDI
Primary DI / UDI-DI
10884527006571 FDA UDI
510(k) Number
K964401 FDA UDI
FDA Product Code
FMT FDA UDI
GMDN Term
Armboard, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5130 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

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

Dimensions & Sizes

Size
Length — 1.25 Inch FDA UDI
Width — 0.75 Inch FDA UDI

Category: Armboard, reusable

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

Similar devices

Also classified as Armboard, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 541ff0f5-9805-4788-bc1b-38914473e592 38 fields · synced May 29, 2026