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Cold Care Pack

FDA UDI

Class I (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name
Cold Care Pack FDA UDI
Generic Name
Cold therapy pack chilling unit FDA UDI
Model / Reference
CP1002 FDA UDI

Identifiers

Primary DI / UDI-DI
00815212022883 FDA UDI
FDA Product Code
IME FDA UDI
GMDN Term
Cold therapy pack chilling unit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5700 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cold therapy pack chilling unit

Cold Care Pack by Izi Medical Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cold therapy pack chilling unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Izi Medical Products Llc

Sources (1)

  • FDA UDI c61e35f2-3b30-4a9b-9d3a-cb3a1e2b73bc 32 fields · synced Jun 1, 2026