FDA UDI Not in Commercial Distribution 🇺🇸 United States

ACCU-CHEK NANO

DI: 00365702637108 · Model: 05423066001 · Roche Diagnostics Operations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ACCU-CHEK NANO
Primary DI
00365702637108
Version / Model
05423066001
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
2023-07-25
Public Version Status
Update
Public Device Record Key
76452a01-35c5-4661-9b96-8948ed4e2750
Distribution End Date
2019-04-16

Device Description

ACCU-CHEK NANO MTR MG/DL (596)

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NBW System, Test, Blood Glucose, Over The Counter

GMDN Terms

Code Name
62645 Glucose analyser IVD, home-use

Identifiers

Type ID
Primary 00365702637108