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TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive FDA UDI
- Generic Name
- Transcutaneous blood gas monitoring system FDA UDI
- Device Name
- TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive (50 pcs) FDA UDI
- Model / Reference
- TC 555 FDA UDI
- Description
- TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive (50 pcs) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07332834000257 FDA UDI
- 510(k) Number
- K990960 FDA UDI
- FDA Product Code
- KLK FDA UDILKD FDA UDI
- GMDN Term
- Transcutaneous blood gas monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2500 FDA UDI868.2480 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous blood gas monitoring system
TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive by Perimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K990960 also covers:
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
- Perimed, Inc.
Sources (1)
- FDA UDI 397bbff8-f435-4250-8f11-b80f16d13020 35 fields · synced Jun 7, 2026