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SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O&MANOMETER PORT
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RE-24438
Identity
- Trade Name
- Single Use Resuscitator with Handstrap, 60cmH2O POP-OFF, 1600ml, Adult EUDAMEDSINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O&MANOMETER PORT FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- Single Use Resuscitator with Handstrap, 60cmH2O POP-OFF, 1600ml, Adult EUDAMEDSINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O&MANOMETER PORT W/HANDSTRAP FDA UDI
- Model / Reference
- RE-24438 EUDAMEDFDA UDI
- Description
- SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O&MANOMETER PORT W/HANDSTRAP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770244389 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04716770244389 EUDAMED
- 510(k) Number
- K021442 FDA UDI
- FDA Product Code
- BTM FDA UDI
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Market of Registration
- Denmark 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
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, manual, single-use
SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O&MANOMETER PORT by Besmed Health Business Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID…
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 22c02214-dc15-4bf7-b243-70aeb07a48ec 34 fields · synced Jun 19, 2026
- EUDAMED 0bcda7b1-ab3f-48f6-ba8b-cf9a3fc2512c 61 fields · synced Jun 19, 2026