FDA UDI In Commercial Distribution 🇺🇸 United States

Synchron

DI: 15099590200046 · Model: 469600 · Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Synchron
Primary DI
15099590200046
Version / Model
469600
Catalog Number
469600
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
ca9e629c-8a6b-4410-a0b8-af2d70a81047

Device Description

SYNCHRON Systems Drug Calibrator 1

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
DKB Calibrators, Drug Mixture

GMDN Terms

Code Name
55234 Multiple-therapy therapeutic drug monitoring IVD, calibrator

Identifiers

Type ID
Primary 15099590200046