Identity
- Trade Name
- Tego™ FDA UDI
- Generic Name
- Haemodialysis tubing valve-connector FDA UDI
- Device Name
- Tego™ Connector FDA UDI
- Model / Reference
- D1000 FDA UDI
- Description
- Tego™ Connector FDA UDI
Identifiers
- Catalog Number
- D1000 FDA UDI
- Primary DI / UDI-DI
- 00840619026059 FDA UDI
- 510(k) Number
- K053106 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Haemodialysis tubing valve-connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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: Haemodialysis tubing valve-connector
Tego™ by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis tubing valve-connector.
- Lyka® PORT Needle Free Access Device — QUEST MEDICAL INC · Class II
- Tego™ — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K053106 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI 5d44ab04-1353-4754-9ba7-c53956fc6294 36 fields · synced May 30, 2026