Identity
- Trade Name
- The Breather Pink EUDAMEDFDA UDI
- Generic Name
- Tongue/lip exerciser FDA UDI
- Device Name
- The Breather EUDAMED
- Model / Reference
- 1 EUDAMEDB-Pink EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850021574789 EUDAMED00865202000193 FDA UDI
- Basic UDI-DI
- 0865202000115A EUDAMED
- Direct Marketing DI
- 00850021574789 EUDAMED
- FDA Product Code
- ION FDA UDI
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
- GMDN Term
- Tongue/lip exerciser FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
No
FDA UDI
Over-the-Counter
Yes
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
The Breather Pink by PN Medical Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0865202000115A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PN Medical Inc
- EUDAMED SRN
- US-MF-000027286
- Authorised Representative
- Luft For Life Österreich Ltd AT-AR-000020403
Sources (2)
- EUDAMED 63257cfd-3337-42b5-b111-0ac0b2c2e69c 61 fields · synced Jul 9, 2026
- FDA UDI 9b2719ca-eabc-44cd-8118-7414305c5757 32 fields · synced May 30, 2026