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Pro-Flow Plus Nasal Oral Cannula, Pediatric
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref P1354Model Pro-Tech Pro-Flow and Pro-Flow Plus Cannulas510(k) K983547
Identity
- Trade Name
- Pro-Flow Plus Nasal Oral Cannula, Pediatric EUDAMED
- Model / Reference
- Pro-Tech Pro-Flow and Pro-Flow Plus Cannulas EUDAMEDP1354 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30606959032256 EUDAMED
- Basic UDI-DI
- B-30606959032256 EUDAMED
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pro-Flow Plus Nasal Oral Cannula, Pediatric by Pro-Tech Services, Inc. — Class I — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983547 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-30606959032256 | Class I | Active |
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Manufacturer
- Manufacturer
- Pro-Tech Services, Inc.
- EUDAMED SRN
- US-MF-000002300
- FDA Applicant
- Protech, Inc.
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED c83c7479-a9c0-4f0d-8a5a-67b0ac7e47ba 85 fields · synced Jun 18, 2026
- EUDAMED e090ca23-b417-4ea6-90a9-55c6c9be998d 61 fields · synced Jun 11, 2026
- FDA 510(k) K983547 1 fields · synced May 18, 2026