Identity
- Trade Name
- CURAPLEX FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- VVC,72UNIV,BIV,2 PRESSURE LINES,PORT,HANGER 20/CA FDA UDI
- Model / Reference
- TA3000 FDA UDI
- Description
- VVC,72UNIV,BIV,2 PRESSURE LINES,PORT,HANGER 20/CA FDA UDI
Identifiers
- Catalog Number
- 301-TA3000EA FDA UDI
- Primary DI / UDI-DI
- 00810071638626 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ventilator breathing circuit, single-use
Curaplex by Bound Tree Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator breathing circuit, single-use.
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- MEDIFLEX — Mediflex Medikal · Class IIa
- ALTECH — Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. · Class IIa
- Infant Resuscitation Kit. T-Piece Circuit — FLEXICARE MEDICAL LIMITED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- AirLife™ — Airlife, Inc. · Class II
- Classic RT — Plastiflex Group NV · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI 8ac979d2-38c2-4ffb-8d49-d0417a778b16 34 fields · synced May 30, 2026