FDA UDI In Commercial Distribution 🇺🇸 United States

GETINGE 46-SERIES

DI: 07340153700017 · Model: 46-4 · Getinge Disinfection AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
GETINGE 46-SERIES
Primary DI
07340153700017
Version / Model
46-4
Catalog Number
46-4-500
Company Name
Getinge Disinfection AB
Labeler DUNS
354023236
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-22
Public Version
3
Public Version Date
2019-04-12
Public Version Status
Update
Public Device Record Key
9f1dccf5-abba-472f-b53b-85451432b542

Device Description

WASHER DISINFECTOR 46-4 S+NO D, where S+NO D indicates single door disifector without dryer. Cat no was 46-4-400. From March 2019 new cat no is 46-4-500.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
PM Exempt
Yes
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
MEC Disinfector, Medical Devices

GMDN Terms

Code Name
35424 Surgical utensil washer/disinfector

Identifiers

Type ID
Primary 07340153700017