FDA UDI Not in Commercial Distribution 🇺🇸 United States

Micro Medical

DI: 54250892980077 · Model: 36-ML3535 MK8-STK · CAREFUSION U.K. 232 LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Micro Medical
Primary DI
54250892980077
Version / Model
36-ML3535 MK8-STK
Catalog Number
36-ML3535 MK8-STK
Company Name
CAREFUSION U.K. 232 LIMITED
Labeler DUNS
291555621
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-04
Public Version
5
Public Version Date
2022-03-08
Public Version Status
Update
Public Device Record Key
576da943-3389-4045-a6b8-19018b0d4941
Distribution End Date
2019-05-20

Device Description

MicroLoop

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BZG Spirometer, Diagnostic

GMDN Terms

Code Name
13680 Diagnostic spirometer, professional

Identifiers

Type ID
Primary 54250892980077

Customer Contacts

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
10 – 90 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
-20 – 70 Degrees Celsius