Identity
- Trade Name
- Smart Lung Infant 0.5 Liter FDA UDI
- Generic Name
- Lung physical simulator FDA UDI
- Device Name
- Test lung (physical simulator) FDA UDI
- Model / Reference
- 300.400.104 FDA UDI
- Description
- Test lung (physical simulator) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640214642387 FDA UDI
- FDA Product Code
- BTC FDA UDI
- GMDN Term
- Lung physical simulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5320 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lung physical simulator
Smart Lung Infant 0.5 Liter by Imt Analytics Inc. — 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
- Imt Analytics Inc.
Sources (1)
- FDA UDI 56875041-d871-4bb8-842c-b0849b2daac0 33 fields · synced May 30, 2026