FDA UDI Not in Commercial Distribution 🇺🇸 United States

Accu-Chek Rapid-D Link

DI: 04015630046096 · Model: 04541081001 · Roche Diabetes Care GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
Accu-Chek Rapid-D Link
Primary DI
04015630046096
Version / Model
04541081001
Catalog Number
04541081001
Company Name
Roche Diabetes Care GmbH
Labeler DUNS
313212471
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2016-08-23
Public Version
4
Public Version Date
2019-04-29
Public Version Status
Update
Public Device Record Key
757e8148-817a-4356-9b7e-1f26821b629a
Distribution End Date
2018-10-23

Device Description

Accu-Chek Rapid-D Link Tra. Set 100 10pc

Device Characteristics

Single Use
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
FPA Set, Administration, Intravascular

GMDN Terms

Code Name
35833 Electric infusion pump administration set, single-use

Identifiers

Type ID
Primary 04015630046096
Unit of Use 54015630046091