FDA UDI In Commercial Distribution 🇺🇸 United States

IMMULITE® Systems GAS CONTROL Gastrin

DI: 00630414953199 · Model: 10385331 · SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
IMMULITE® Systems GAS CONTROL Gastrin
Primary DI
00630414953199
Version / Model
10385331
Catalog Number
LGACM
Company Name
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Labeler DUNS
296822794
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-24
Public Version
2
Public Version Date
2021-11-18
Public Version Status
Update
Public Device Record Key
648dfe68-6be4-4542-bdc0-3da4330d4668

Device Description

Gastrin - IMMULITE - CTL - 2x2mL

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MSW System,test,thyroglobulin

GMDN Terms

Code Name
54193 Gastrin IVD, control

Identifiers

Type ID
Primary 00630414953199

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius