Identity
- Trade Name
- Rescuer Silicone Resuscitation Mask (#2 Infant) FDA UDI
- Generic Name
- Resuscitator face mask, reusable FDA UDI
- Device Name
- Rescuer Silicone Resuscitation Mask (#2 Infant) FDA UDI
- Model / Reference
- 2525 FDA UDI
- Description
- Rescuer Silicone Resuscitation Mask (#2 Infant) FDA UDI
Identifiers
- Catalog Number
- 2525 FDA UDI
- Primary DI / UDI-DI
- B00225250 FDA UDI
- FDA Product Code
- BSJ FDA UDI
- GMDN Term
- Resuscitator face mask, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5550 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Resuscitator face mask, reusable
Rescuer Silicone Resuscitation Mask (#2 Infant) by B.L.S. Systems Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Resuscitator face mask, reusable.
- Silicone Face Mask — Ambu A/S · Class I
- mada — ENTER MEDICAL CORPORATION · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- Silicone Face Mask — Ambu A/S · Class I
- FERNO2 — SPIRACLE TECHNOLOGY · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- INTL DEMAND VALVE ASSY-CENT.MX — Parker Hannifin Corp. · 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
- B.L.S. Systems Limited
Sources (1)
- FDA UDI f2943967-1605-4959-a90b-f2399e449165 36 fields · synced May 30, 2026