FDA UDI In Commercial Distribution 🇺🇸 United States

SJM™

DI: 05414734500258 · Model: AC-DP-3 · ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
SJM™
Primary DI
05414734500258
Version / Model
AC-DP-3
Catalog Number
AC-DP-3
Company Name
ST. JUDE MEDICAL, INC.
Labeler DUNS
790268031
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-06
Public Version
6
Public Version Date
2021-03-19
Public Version Status
Update
Public Device Record Key
99eda95c-6cd7-4393-81cb-1c1066ec0475

Device Description

DF-1 (3.2 mm) RECEPTACLE PLUG

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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LWS Implantable cardioverter defibrillator (non-CRT)

GMDN Terms

Code Name
44900 Implantable pulse generator port plug

Identifiers

Type ID
Primary 05414734500258
Secondary H758ACDP30

Customer Contacts

Device Sizes

Type Value Unit Text
Outer Diameter 3.2 Millimeter

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
32 – 104 Degrees Fahrenheit
Type
Handling Environment Temperature
Temperature Range
0 – 40 Degrees Celsius
Type
Storage Environment Temperature
Temperature Range
0 – 40 Degrees Celsius
Type
Handling Environment Temperature
Temperature Range
32 – 104 Degrees Fahrenheit