Identity
- Trade Name
- MediByte Patient Kit FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Battery, 8597 Oronasal cannula. FDA UDI
- Model / Reference
- 8115-25 FDA UDI
- Description
- Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Battery, 8597 Oronasal cannula. FDA UDI
Identifiers
- Catalog Number
- 8115-25 FDA UDI
- Primary DI / UDI-DI
- B1408115251 FDA UDI
- FDA Product Code
- CAT FDA UDI
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5340 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: Gas-sampling/monitoring respiratory tubing, single-use
MediByte Patient Kit by Braebon Medical Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Braebon Medical Corp.
Sources (1)
- FDA UDI 9871fb03-4744-44e1-9cce-458b39f9e813 35 fields · synced Jun 6, 2026