Identity
- Trade Name
- Manifold FDA UDI
- Generic Name
- Infusion line manifold FDA UDI
- Device Name
- Right on 500PSI FDA UDI
- Model / Reference
- M-04 FDA UDI
- Description
- Right on 500PSI FDA UDI
Identifiers
- Catalog Number
- 125004 FDA UDI
- Primary DI / UDI-DI
- 06971162817253 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Infusion line manifold FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4290 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infusion line manifold
Manifold by Tianck Medical Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tianck Medical Co., Ltd.
Sources (2)
- FDA UDI a834bcbe-a648-4476-b41d-2917b0d002c8 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026