Identity
- Trade Name
- Tecotherm FDA UDI
- Generic Name
- Intravenous/irrigation solution storage container, reusable FDA UDI
- Device Name
- TC-CRS Fill-up set for Serial numbers 2015/24/01 and higher FDA UDI
- Model / Reference
- TC-CRS FDA UDI
- Description
- TC-CRS Fill-up set for Serial numbers 2015/24/01 and higher FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060206921740 FDA UDI
- FDA Product Code
- FPF FDA UDI
- GMDN Term
- Intravenous/irrigation solution storage container, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6085 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intravenous/irrigation solution storage container, reusable
Tecotherm by Inspiration Healthcare, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous/irrigation solution storage container, reusable.
- Tecotherm — Inspiration Healthcare, Ltd. · Class I
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
- Inspiration Healthcare, Ltd.
Sources (1)
- FDA UDI 157ac857-39dc-4052-800d-6f2a39e7228b 34 fields · synced Jun 1, 2026