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Silicone Infant 280ml Resuscitator W/ Pop-Off 40cm H2o, L Type Adapter
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RE-23330
Identity
- Trade Name
- Reusable Resuscitator 280 ml W/ 40 cm H2O POP-OFF EUDAMEDSILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM H2O, L TYPE ADAPTER FDA UDI
- Generic Name
- Pulmonary resuscitator, pneumatic, reusable FDA UDI
- Device Name
- Reusable Resuscitator 280 ml W/ 40 cm H2O POP-OFF EUDAMED
- Model / Reference
- RE-23330 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770233307 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04716770233307 EUDAMED
- 510(k) Number
- K021446 FDA UDI
- FDA Product Code
- BTM FDA UDI
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
- GMDN Term
- Pulmonary resuscitator, pneumatic, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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, pneumatic, reusable
Silicone Infant 280ml Resuscitator W/ Pop-Off 40cm H2o, L Type Adapter by Besmed Health Business Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Pulmonary resuscitator, pneumatic, reusable.
- CAREvent CA — O-Two Medical Technologies Inc · Class II
- CAREvent DRA — O-Two Medical Technologies Inc · Class II
- Pneupac — ICU MEDICAL, INC. · Class II
- CAREvent ALS — O-Two Medical Technologies Inc
- Life Support Products — Allied Medical LLC · Class II
- Puffin Lite Infant Resuscitator — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- CAREvent ALS+ — O-Two Medical Technologies Inc · Class II
- Life Support Products — Allied Medical LLC · Class II
Cleared under the same submission
K021446 also covers:
- CPR POCKET RESUSCITATOR W/O TUBE (BLOW MOLDING) — BESMED HEALTH BUSINESS CORP.
- Reusable Resuscitator — BESMED HEALTH BUSINESS CORP.
- SILICONE ADULT 1000ML RESUSCITATOR W/ POP-OFF 60CM H2O — BESMED HEALTH BUSINESS CORP.
- SILICONE ADULT 1000ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- SILICONE ADULT 1000ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- SILICONE ADULT 1000ML RESUSCITATOR W/O POP-OFF — BESMED HEALTH BUSINESS CORP.
- SILICONE ADULT 1000ML RESUSCITATOR W/O POP-OFF — BESMED HEALTH BUSINESS CORP.
- SILICONE ADULT 1000ML RESUSCITATOR W/O POP-OFF , L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- SILICONE ADULT 1000ML RESUSCITATOR W/O POP-OFF , L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.
- SILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60CM H2O — BESMED HEALTH BUSINESS CORP.
- SILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60CM H2O — BESMED HEALTH BUSINESS CORP.
- SILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60CM H2O — 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 dc0897c5-8311-4eb4-8885-6a35334d3d0c 33 fields · synced Jun 19, 2026
- EUDAMED 2f8c17f0-4786-43af-8a56-8353df5e898b 61 fields · synced Jun 19, 2026