Identity
- Trade Name
- Thermo Scientific Forma FDA UDI
- Generic Name
- Assisted reproduction heater/incubator FDA UDI
- Device Name
- Water Jacketed CO2 Incubator FDA UDI
- Model / Reference
- 3140 FDA UDI
- Description
- Water Jacketed CO2 Incubator FDA UDI
Identifiers
- Catalog Number
- 3140 FDA UDI
- Primary DI / UDI-DI
- 10815773020141 FDA UDI
- 510(k) Number
- K991408 FDA UDI
- FDA Product Code
- MQG 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assisted reproduction heater/incubator
Thermo Scientific Forma by Thermo Fisher Scientific (Asheville) LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Assisted reproduction heater/incubator.
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- COOK — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class II
- Dry Incubator — ASTEC CO., LTD. · Class II
- K-Systems — Research Instruments , Ltd. · Class II
- CT37 Incubator — PLANER LIMITED · Class II
- HARIOMED — Hua Yue Medical Technology Co., Ltd. · Class II
Cleared under the same submission
K991408 also covers:
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC
- Thermo Scientific Forma — Thermo Fisher Scientific (Asheville) LLC
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
- Thermo Fisher Scientific (Asheville) LLC
Sources (1)
- FDA UDI b0f94b5e-52f0-4e96-a759-8969f0f877ec 37 fields · synced Jun 9, 2026