Identity
- Trade Name
- Protekt Regulator FDA UDI
- Generic Name
- Oxygen therapy conserving regulator FDA UDI
- Device Name
- Oxygen Regulator, 0-8 LPM Full Size, CGA 870, Barb Outlet - Master Carton - Qty 20 FDA UDI
- Model / Reference
- PMREG08B FDA UDI
- Description
- Oxygen Regulator, 0-8 LPM Full Size, CGA 870, Barb Outlet - Master Carton - Qty 20 FDA UDI
Identifiers
- Catalog Number
- PMREG08B FDA UDI
- Primary DI / UDI-DI
- 05060488573255 FDA UDI
- FDA Product Code
- CAN FDA UDI
- GMDN Term
- Oxygen therapy conserving regulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 7.5 Inch FDA UDIWidth — 16 Inch FDA UDIHeight — 11.5 Inch FDA UDI
Category: Oxygen therapy conserving regulator
Protekt Regulator by Proactive Medical Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen therapy conserving regulator.
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
- VYGON — Vygon Corp. · Class I
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
- Easy Pulse 5 Oxygen Conserving Regulator — PRECISION MEDICAL, INC. · Class II
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Proactive Medical Products
Sources (1)
- FDA UDI 0a2bd15d-3a53-4535-af69-4d94130550b1 36 fields · synced May 30, 2026