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Delfi Pedi-Fit Tourniquet Cuff Single Use Sp Sb Cylindrical P3.0 With Matching …
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 60-9700-003-00
Identity
- Trade Name
- Pedi-Fit Sterile Single Use FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- DELFI PEDI-FIT TOURNIQUET CUFF SINGLE USE SP SB CYLINDRICAL P3.0 WITH MATCHING LIMB PROTECTION SLEEVE EUDAMEDDelfi single use tourniquet cuffs are available in various models for pediatric and adult patients. Available in a selection of lengths and widths to facilitate a proper fit, and color coded for size identification. Single use tourniquet cuffs are intended for single use only. FDA UDI
- Model / Reference
- 60-9700-003-00 EUDAMEDFDA UDI
- Description
- Delfi single use tourniquet cuffs are available in various models for pediatric and adult patients. Available in a selection of lengths and widths to facilitate a proper fit, and color coded for size identification. Single use tourniquet cuffs are intended for single use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M995609700003003 EUDAMEDM995609700003001 FDA UDI
- Basic UDI-DI
- B-M995609700003003 EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139006 PNEUMATIC TOURNIQUETS EUDAMED
- GMDN Term
- Tourniquet cuff, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Delfi Pedi-Fit Tourniquet Cuff Single Use Sp Sb Cylindrical P3.0 With Matching … by Delfi Medical Innovations Inc. — Class IIa — MDD, FDA UDI — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-M995609700003003 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Delfi Medical Innovations Inc.
- EUDAMED SRN
- CA-MF-000004434
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (2)
- EUDAMED 926381f6-378c-40d1-baaf-4eedbf6485de 61 fields · synced Jun 19, 2026
- FDA UDI dfbab729-2e28-4fa1-9a0c-372a7ba6c0d9 34 fields · synced May 29, 2026