Identity
- Trade Name
- TubeChek-B FDA UDI
- Generic Name
- Exhaled-gas oesophageal intubation detector FDA UDI
- Device Name
- Ambu TubeChek B, Bulb model Minimum order sales is 20 pcs. FDA UDI
- Model / Reference
- 000172002 FDA UDI
- Description
- Ambu TubeChek B, Bulb model Minimum order sales is 20 pcs. FDA UDI
Identifiers
- Catalog Number
- 000172002 FDA UDI
- Primary DI / UDI-DI
- 05707480134885 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Exhaled-gas oesophageal intubation detector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5730 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 45 Gram FDA UDIOuter Diameter — 59 Millimeter FDA UDILength — 83 Millimeter FDA UDI
TubeChek-B by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Ambu A/S
Sources (1)
- FDA UDI fa7fd55a-1320-4e61-a49a-0b246fac8527 38 fields · synced May 30, 2026