Identity
- Trade Name
- BT37 FDA UDI
- Generic Name
- Assisted reproduction heater/incubator FDA UDI
- Device Name
- BT37 Mark 2, Benchtop Incubator FDA UDI
- Model / Reference
- BT37-02 FDA UDI
- Description
- BT37 Mark 2, Benchtop Incubator FDA UDI
Identifiers
- Catalog Number
- GDBT37-02-CS FDA UDI
- Primary DI / UDI-DI
- B199GDBT3702CS0 FDA UDI
- FDA Product Code
- PUB FDA UDI
- GMDN Term
- Assisted reproduction heater/incubator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6120 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: Assisted reproduction heater/incubator
Bt37 by Planer Limited — 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
- Planer Limited
Sources (1)
- FDA UDI 1d25fb6d-190e-4ef3-9df9-e82c3e814eef 34 fields · synced May 30, 2026