Identity
- Trade Name
- Interactive Breath Hold Monitor FDA UDI
- Generic Name
- Breath-hold system FDA UDI
- Device Name
- Interactive Breath Hold Monitor FDA UDI
- Model / Reference
- IBC01 FDA UDI
- Description
- Interactive Breath Hold Monitor FDA UDI
Identifiers
- Catalog Number
- 43T0970 FDA UDI
- Primary DI / UDI-DI
- 00851607003082 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Breath-hold system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breath-hold system
Interactive Breath Hold Monitor by Medspira Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breath-hold system.
- Monitor System, US Power Cord & Convertor — MEDSPIRA 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medspira Llc
Sources (1)
- FDA UDI 41b65461-3234-49f6-a2aa-d6e44a960713 36 fields · synced May 30, 2026