FDA UDI In Commercial Distribution 🇺🇸 United States

VITROS

DI: 10758750033201 · Model: 6900440 · ORTHO-CLINICAL DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VITROS
Primary DI
10758750033201
Version / Model
6900440
Catalog Number
6900440
Company Name
ORTHO-CLINICAL DIAGNOSTICS, INC.
Labeler DUNS
623873044
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-31
Public Version
4
Public Version Date
2023-06-21
Public Version Status
Update
Public Device Record Key
de325db5-5665-42aa-ac6a-b8752f3854d7

Device Description

VITROS 4600 Chemistry System - Refurbished

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
Yes
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

GMDN Terms

Code Name
56676 Multiple clinical chemistry analyser IVD, laboratory

Identifiers

Type ID
Primary 10758750033201

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-23.3 – 65.5 Degrees Celsius