Identity
- Trade Name
- Ventlab FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- INFANT BAG W/02 RESERVOIR,MASK,PEEP ADPT & PEEP VALVE FDA UDI
- Model / Reference
- BT2011 FDA UDI
- Description
- INFANT BAG W/02 RESERVOIR,MASK,PEEP ADPT & PEEP VALVE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10889483088784 FDA UDI
- 510(k) Number
- K953107 FDA UDI
- FDA Product Code
- BSJ FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 300 Milliliter FDA UDI
Category: Pulmonary resuscitator, manual, single-use
Ventlab by Ventlab Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- VT Sure — Pulmodyne Inc. · Class II
- SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- Rescu-7 Reservoir bag, 600ml — GaleMed Corporation · Class IIa
- AirLife™ — Airlife, Inc. · Class II
- Portex — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K953107 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Ventlab — Ventlab Corp.
- Ventlab — Ventlab Corp.
- Ventlab — Ventlab Corp.
- Ventlab — Ventlab Corp.
- Ventlab — Ventlab Corp.
- Ventlab — Ventlab Corp.
- Ventlab — Ventlab Corp.
- Ventlab — Ventlab Corp.
- Ventlab — Ventlab Corp.
- Ventlab — Ventlab Corp.
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 |
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Manufacturer
- Manufacturer
- Ventlab Corp.
Sources (1)
- FDA UDI 3346f159-3e86-4503-a275-b36117675b80 37 fields · synced Jun 1, 2026