FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 00763000181185 · Model: 2292 · MEDTRONIC, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NA
Primary DI
00763000181185
Version / Model
2292
Company Name
MEDTRONIC, INC.
Labeler DUNS
006261481
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-30
Public Version
1
Public Version Date
2023-02-07
Public Version Status
New
Public Device Record Key
1162c903-ed02-4cdc-ac66-836d3a8153d7

Device Description

CABLE 2292 MDT GLBL

Device Characteristics

Single Use
No
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
No
Sterilization Prior Use
Yes
Sterilization Methods
["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code Name
KRG Programmer, pacemaker
FQM BANDAGE, ELASTIC
OSR Pacemaker/icd/crt non-implanted components

GMDN Terms

Code Name
47487 Electrical-only medical device connection cable, reusable

Identifiers

Type ID
Primary 00763000181185

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
P890003 437

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
– 95 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
15 – 30 Degrees Celsius
Type
Handling Environment Temperature
Temperature Range
-40 – 70 Degrees Celsius