FDA UDI In Commercial Distribution 🇺🇸 United States

MicroScan

DI: 15099590693404 · Model: B1020-100B · Beckman Coulter, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
20

Basic Information

Brand Name
MicroScan
Primary DI
15099590693404
Version / Model
B1020-100B
Company Name
Beckman Coulter, Inc.
Labeler DUNS
008254708
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
Record Status
Published
Publish Date
2017-08-02
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
4cfed81f-80a1-4330-aac6-ac17c2d2d365

Device Description

Detect Neg MIC Panel Type 1

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OTT Research Use Only/Microbiology
JWY Manual Antimicrobial Susceptibility Test Systems

GMDN Terms

Code Name
58605 General-microorganism antimicrobial susceptibility culture medium IVD

Identifiers

Type ID
Primary 15099590693404
Unit of Use 05099590693407

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 25 Degrees Celsius