FDA UDI In Commercial Distribution 🇺🇸 United States

LEAKAGE TESTER

DI: 04953170065163 · Model: MB-155 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LEAKAGE TESTER
Primary DI
04953170065163
Version / Model
MB-155
Catalog Number
GX9381
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-21
Public Version
7
Public Version Date
2023-12-28
Public Version Status
Update
Public Device Record Key
a47a39c9-880b-45bc-9bf9-c885cffeff42

Device Description

"MB-155 LEAKAGE TESTER FOR MU-1"

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FDS Gastroscope And Accessories, Flexible/Rigid
FDF Colonoscope And Accessories, Flexible/Rigid
NWB Endoscope, Accessories, Narrow Band Spectrum

GMDN Terms

Code Name
37006 Invasive medical device leak tester, electrical

Identifiers

Type ID
Primary 04953170065163

Customer Contacts