Perineal Instant Cold Pack with self adhesive strip

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Perineal Instant Cold Pack with self adhesive strip FDA UDI
Generic Name: Hot/cold therapy pack, single-use FDA UDI
Model / Reference: 4515 FDA UDI

Identifiers

Primary DI / UDI-DI: 00616784451534 FDA UDI
FDA Product Code: IMD FDA UDI
GMDN Term: Hot/cold therapy pack, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5710 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hot/cold therapy pack, single-use

Perineal Instant Cold Pack with self adhesive strip by Dynarex Corp. — 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: Dynarex Corp.

Sources (1)

FDA UDI 1fd425be-677f-4bfe-9a19-90cf50eb308d 32 fields · synced May 29, 2026