Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- Curaplex Bag Valve Mask (BVM), Adult, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs FDA UDI
- Model / Reference
- 30070 FDA UDI
- Description
- Curaplex Bag Valve Mask (BVM), Adult, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815277025348 FDA UDI
- 510(k) Number
- K053466 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
Dimensions & Sizes
- Size
- Total Volume — 1500 Milliliter FDA UDI
Category: Pulmonary resuscitator, manual, single-use
Curaplex by Bound Tree Medical, Llc — 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
K053466 also covers:
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Sunmed — SunMed
- Sunmed — SunMed
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 13a317d0-ca38-4972-bf35-924d75795d72 35 fields · synced Jun 8, 2026