Identity
- Trade Name
- D130/D131 KIDS Arterial Filter FDA UDI
- Generic Name
- Medical device service rail clamp FDA UDI
- Model / Reference
- D634 Holder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033178109864 FDA UDI
- FDA Product Code
- KRI FDA UDI
- GMDN Term
- Medical device service rail clamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4200 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
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: Medical device service rail clamp
D130/D131 KIDS Arterial Filter by Sorin Group Italia Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device service rail clamp.
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- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- CAPIOX — Terumo Corp. · Class I
- ASSISTO® Arm-System — Geomed Medizin-Technik GmbH & Co. KG · 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
- Sorin Group Italia Srl
Sources (1)
- FDA UDI c2ddf660-11e2-4a66-80ca-79d53710b794 32 fields · synced May 30, 2026