Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- RESUS,ADL,MASK,OXY TUBE,RESV 10/CA FDA UDI
- Model / Reference
- 301-C1000 FDA UDI
- Description
- RESUS,ADL,MASK,OXY TUBE,RESV 10/CA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812574020830 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
Curaplex by Tri-Anim Health Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 (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 II | Pending data |
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Manufacturer
- Manufacturer
- Tri-Anim Health Services, Inc.
Sources (1)
- FDA UDI a877c016-4d4f-4c94-b11c-d3c7c6052a42 34 fields · synced May 31, 2026