FDA UDI
In Commercial Distribution
🇺🇸 United States
SJM™
DI: 05414734506441
·
Model: 4023
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SJM™
- Primary DI
- 05414734506441
- Version / Model
- 4023
- Catalog Number
- 4023
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 790268031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-10
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- a6e856cb-ab97-41eb-ac7a-ed9a4a15baa5
Device Description
ADAPTING SLEEVE KIT
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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DTD | pacemaker lead Adaptor | Cardiovascular | 870.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36102 | Pacing/defibrillation lead electrical adaptor | An implantable device designed to adapt the electrical connectors of an implanted pacemaker and/or defibrillator pacing lead to a non-compatible pacemaker or defibrillator (i.e., when they do not meet connection design). This device is implanted with the pacemaker or defibrillator system. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05414734506441 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K921318 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.2 | Millimeter | |
| Length | 5 | Millimeter | |
| Outer Diameter | 6 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 23 – 122 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 23 – 122 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 50 Degrees Celsius