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Fluid pack
EUDAMEDFDA UDIClass A (EU MDR)
Ref CD-478701-4DRef DD-61012DRef ME-2123D
Identity
- Trade Name
- Fluid pack EUDAMEDPack, 800mL, Na/K/Ca/pH FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, control FDA UDI
- Device Name
- CONDITONER, FLUIDS PACK EUDAMEDFluid Pack, Unity EUDAMEDFluid Pack Eastlyte Na-K-Ca-pH EUDAMEDProvide calibration points for the Na, K, Cl and Li electrodes. FDA UDI
- Model / Reference
- CD-478701-4D EUDAMEDDD-61012D EUDAMEDME-2123D EUDAMEDFDA UDI
- Description
- Provide calibration points for the Na, K, Cl and Li electrodes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403010332 EUDAMED00811403010363 EUDAMED00811403015917 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301CD4787014DJH EUDAMED081140301DD61012D7X EUDAMED081140301ME2123DDD EUDAMED
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
- GMDN Term
- Multiple blood gas analyte IVD, control FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Hungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Fluid pack by DIAMOND DIAGNOSTICS Inc — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081140301CD4787014DJH | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Diamond Diagnostics Inc
- EUDAMED SRN
- US-MF-000035435
- Authorised Representative
- Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351
Sources (4)
- EUDAMED b49c7c80-afdb-4927-bf22-2680fcc728a3 61 fields · synced Aug 4, 2026
- EUDAMED 4dec36cd-dfb5-480b-8ebd-8ec39d8f4772 61 fields · synced May 18, 2026
- EUDAMED ea4aae08-1805-417a-a4c7-466f01e1f0ba 61 fields · synced May 18, 2026
- FDA UDI 8a81dc38-d899-4c79-a147-3eb03db99bce 33 fields · synced May 30, 2026