Identity
- Trade Name
- imtmedical FDA UDI
- Generic Name
- Breathing circuit gas-sampling/monitoring set FDA UDI
- Device Name
- iFlow 40 S Neonatal/Infant Proximal Flow Sensor FDA UDI
- Model / Reference
- 301.470.010 FDA UDI
- Description
- iFlow 40 S Neonatal/Infant Proximal Flow Sensor FDA UDI
Identifiers
- Catalog Number
- 301.470.010 FDA UDI
- Primary DI / UDI-DI
- 07640149381351 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Breathing circuit gas-sampling/monitoring set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breathing circuit gas-sampling/monitoring set
imtmedical by Imtmedical Pte. Ltd. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Imtmedical Pte. Ltd.
Sources (1)
- FDA UDI ed463a94-a203-494a-ae8c-b88e1107e4c1 36 fields · synced Jun 8, 2026