FDA UDI Not in Commercial Distribution 🇺🇸 United States

ACCU-CHEK 360

DI: 00365702508101 · Model: 06604765001 · Roche Diagnostics Operations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ACCU-CHEK 360
Primary DI
00365702508101
Version / Model
06604765001
Catalog Number
06604765001
Company Name
Roche Diagnostics Operations, Inc.
Labeler DUNS
141608724
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-26
Public Version
3
Public Version Date
2021-09-20
Public Version Status
Update
Public Device Record Key
d3e395d5-9927-48d1-942d-b32d3d59f025
Distribution End Date
2021-09-17

Device Description

ACCU-CHEK 360 INSULIN PUMP CONFIG SW US

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MRZ Accessories, Pump, Infusion

GMDN Terms

Code Name
44081 Home healthcare information system application software

Identifiers

Type ID
Primary 00365702508101