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Single Use Child 500ml Resuscitator W/ Pop-Off 40cm H2o (all In One-Intake Valve
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CM H2O (ALL IN ONE-INTAKE VALVE FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CM H2O (ALL IN ONE-INTAKE VALVE) FDA UDI
- Model / Reference
- RE-24510 FDA UDI
- Description
- SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CM H2O (ALL IN ONE-INTAKE VALVE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770245102 FDA UDI
- 510(k) Number
- K021442 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 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
Category: Pulmonary resuscitator, manual, single-use
Single Use Child 500ml Resuscitator W/ Pop-Off 40cm H2o (all In One-Intake Valve by Besmed Health Business Corp. — Class II — MDD, FDA UDI — listed in FDA…
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
- Ventlab — Ventlab Corp. · Class II
- 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
- Ventlab — Ventlab Corp. · Class I
- Ventlab — Ventlab Corp. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
Cleared under the same submission
K021442 also covers:
- RUBBER ADULT 1000ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- RUBBER ADULT 1000ML RESUSCITATOR W/O POP-OFF , L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- RUBBER ADULT 1700ML RESUSCITATOR W/ POP-OFF 60CM H2O — BESMED HEALTH BUSINESS CORP.
- RUBBER ADULT 1700ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- RUBBER CHILD 550ML RESUSCITATOR W/ POP-OFF 40CM H2O, L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- RUBBER INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM H2O — BESMED HEALTH BUSINESS CORP.
- RUBBER INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM H2O, L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- SINGLE USE ADULT 1000ML RESUSCITATOR W/ POP-OFF 60CM H2O — BESMED HEALTH BUSINESS CORP.
- SINGLE USE ADULT 1000ML RESUSCITATOR W/O POP-OFF , L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- SINGLE USE ADULT 1000ML RESUSCITATOR W/O POP-OFF , L TYPE ADAPTER, HAND STRAP — BESMED HEALTH BUSINESS CORP.
- SINGLE USE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- SINGLE USE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
Sources (2)
- FDA UDI f2fa633d-44fb-4eb6-811a-b8b3e12e9777 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026