FDA UDI Not in Commercial Distribution 🇺🇸 United States

Globe Scientific

DI: 00840095607339 · Model: 5132 · GLOBE SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24

Basic Information

Brand Name
Globe Scientific
Primary DI
00840095607339
Version / Model
5132
Company Name
GLOBE SCIENTIFIC INC.
Labeler DUNS
106793995
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
24
Record Status
Published
Publish Date
2019-11-26
Public Version
3
Public Version Date
2021-11-18
Public Version Status
Update
Public Device Record Key
02e603a0-aab9-453a-b495-7ed9b72571ad
Distribution End Date
2021-11-17

Device Description

HITACHI: Cuvette, for use with Hitachi 704 & 705 analyzers, 6/Set, 4 Sets/Unit

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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

GMDN Terms

Code Name
61032 Laboratory analyser cuvette IVD, single-use

Identifiers

Type ID
Primary 00840095607339
Unit of Use 00840095611480