Identity
- Trade Name
- Atellica IM IRI DIL FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- Insulin (IRI) Diluent Bottle Atellica IM - CONS) 1 x 10mL FDA UDI
- Model / Reference
- 10995631 FDA UDI
- Description
- Insulin (IRI) Diluent Bottle Atellica IM - CONS) 1 x 10mL FDA UDI
Identifiers
- Catalog Number
- 10995631 FDA UDI
- Primary DI / UDI-DI
- 00630414600475 FDA UDI
- FDA Product Code
- CFP FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1405 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
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: Buffered sample diluent IVD
Atellica IM IRI DIL by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 5fb56f31-5922-4cf5-937a-582eb138f15d 36 fields · synced Jun 8, 2026