FDA UDI In Commercial Distribution 🇺🇸 United States

ARCHITECT

DI: 00380740019341 · Model: 9D31-20 · ABBOTT LABORATORIES
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ARCHITECT
Primary DI
00380740019341
Version / Model
9D31-20
Catalog Number
09D3120
Company Name
ABBOTT LABORATORIES
Labeler DUNS
117245596
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-09
Public Version
4
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
69eb3687-0e52-45ca-a869-c8d03de1ba13

Device Description

Alkaline Wash

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
JGS ELECTRODE, ION SPECIFIC, SODIUM

GMDN Terms

Code Name
58236 Buffered wash solution IVD

Identifiers

Type ID
Primary 00380740019341

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
15 – 30 Degrees Celsius