Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- Curaplex CPR AED Responder Kit, Heartsmart FDA UDI
- Model / Reference
- 670248-KIT FDA UDI
- Description
- Curaplex CPR AED Responder Kit, Heartsmart FDA UDI
Identifiers
- Catalog Number
- 670248-KIT FDA UDI
- Primary DI / UDI-DI
- 00810094573850 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: First aid kit, non-medicated, reusableCardiopulmonary resuscitation mask, reusable
Curaplex by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary resuscitation mask, reusable.
- MICROTEK — Microtek Medical LLC · Class II
- OP - First aid series — Yiwu Ori-Power Medtech Co., Ltd. · Class I
- Pocket Mask O2, SP Black Private Label — Laerdal Medical Corp. · Class I
- Adsafe™ — American Diagnostic Corporation · Class I
- MICROTEK — Microtek Medical LLC · Class II
- Pocket Mask w/O2, SP (Black IE) — Laerdal Medical Corp. · Class II
- HEADSTAR — Headstar Medical Products Co., Ltd. · Class I
- MICROTEK — Microtek Medical LLC · Class II
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
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI 18c7b159-7be5-48e9-9b8e-603b274427df 34 fields · synced Jun 8, 2026