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Cpr Pocket Resuscitator W/O Tube (blow Molding)
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref CP-66230
Identity
- Trade Name
- Cardiopulmonary Resuscitation Pocket Resuscitator Set EUDAMEDCPR POCKET RESUSCITATOR W/O TUBE (BLOW MOLDING) FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- CPR Pocket Resuscitator Set EUDAMEDCPR POCKET RESUSCITATOR W/O TUBE (BLOW MOLDING) FDA UDI
- Model / Reference
- CP-66230 EUDAMEDFDA UDI
- Description
- CPR POCKET RESUSCITATOR W/O TUBE (BLOW MOLDING) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770662305 EUDAMEDFDA UDI
- Basic UDI-DI
- 4716770CP06600DR EUDAMED
- Direct Marketing DI
- 04716770662305 EUDAMED
- 510(k) Number
- K021446 FDA UDI
- FDA Product Code
- BTM FDA UDI
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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: Cardiopulmonary resuscitation mask, single-use
Cpr Pocket Resuscitator W/O Tube (blow Molding) by Besmed Health Business Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Cardiopulmonary resuscitation mask, single-use.
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- MedSource Emergency Pocket Care Mask, w/o O2 port, Hard Case — MEDSOURCE INTERNATIONAL LLC · Class II
- Rescue Breather — O-Two Medical Technologies Inc · Class I
- EMT - Duke Energy TD - Red Bag — Certified Safety Manufacturing, Inc. · Class II
- ZLB - 10 - Metra 49-980170 — Certified Safety Manufacturing, Inc. · Class II
Cleared under the same submission
K021446 also covers:
- 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.
- SILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60CM H2O — BESMED HEALTH BUSINESS CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 56b8db6f-090a-4ee6-9b63-85b5cd78d8b0 34 fields · synced Aug 3, 2026
- EUDAMED 7d7a31c9-e85d-483d-a10d-59eba2ae226f 61 fields · synced Aug 3, 2026