← Back to catalogue
Pc Kodiak Intl
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 100291-000Model DOC 1000-01 POLAR CARE KODIAK
by Breg, Inc.
Identity
- Trade Name
- PC KODIAK INTL EUDAMEDBREG FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Device Name
- 1 6 VDC output, 100-240 VAC 50-60 hz input transformer FDA UDI
- Model / Reference
- DOC 1000-01 POLAR CARE KODIAK EUDAMED100291-000 EUDAMEDPC KODIAK INTL FDA UDI
- Description
- 1 6 VDC output, 100-240 VAC 50-60 hz input transformer FDA UDI
Identifiers
- Catalog Number
- 100291-000 FDA UDI
- Primary DI / UDI-DI
- 00672736026694 EUDAMEDFDA UDI
- Basic UDI-DI
- 0672736000608P EUDAMED
- FDA Product Code
- ILO FDA UDI
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- GMDN Term
- Inflatable hot/cold therapy pack/electric pump FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5720 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hot/cold therapy pack, reusable
Pc Kodiak Intl by Breg, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
- Hot Cold Pack - Universal customized Cartoon pack Jurassic & Gabby's Dollhouse — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- HOT/COLD THERAPY SLIPPER — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- PRONTO MED — Eurosirel Spa · Class IIa
- HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0672736000608P | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Breg, Inc.
- EUDAMED SRN
- US-MF-000018362
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 4b293c21-e1e7-4302-b145-163dab50c951 61 fields · synced Jul 28, 2026
- FDA UDI d4255744-b00a-48e3-9174-f0706d3efdfe 36 fields · synced May 30, 2026