FDA UDI Not in Commercial Distribution 🇺🇸 United States

NA

DI: 00721902187063 · Model: 5846V · MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
NA
Primary DI
00721902187063
Version / Model
5846V
Company Name
MEDTRONIC, INC.
Labeler DUNS
006261481
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2014-09-23
Public Version
5
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
1d0dc069-aa8c-467f-87fd-dc4f947db668
Distribution End Date
2018-06-21

Device Description

CABLE 5846V 5PK SURG SHRD DSPL 6FT GLBL

Device Characteristics

Single Use
Yes
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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LWP Implantable pulse generator, pacemaker (non-CRT)

GMDN Terms

Code Name
47143 Electrical-only medical device connection cable, single-use

Identifiers

Type ID
Package 10721902187060
Primary 00721902187063

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
P820003 000

Device Sizes

Type Value Unit Text
Length 6.0 Feet

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
– 95 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
-40 – 158 Degrees Fahrenheit