FDA UDI In Commercial Distribution 🇺🇸 United States

Synchron

DI: 15099590222185 · Model: 467983 · Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Synchron
Primary DI
15099590222185
Version / Model
467983
Catalog Number
467983
Company Name
Beckman Coulter, Inc.
Labeler DUNS
008254708
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-24
Public Version
4
Public Version Date
2023-08-28
Public Version Status
Update
Public Device Record Key
5edc6fa9-8408-466a-9698-03a34ca26b92

Device Description

Tobramycin Reagent (TOB 2 x 100)

Device Characteristics

Single Use
Yes
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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LCR Fluorescent Immunoassay, Tobramycin

GMDN Terms

Code Name
55308 Tobramycin therapeutic drug monitoring IVD, reagent

Identifiers

Type ID
Primary 15099590222185