FDA UDI
In Commercial Distribution
🇺🇸 United States
SJM™
DI: 05414734506458
·
Model: 4033
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SJM™
- Primary DI
- 05414734506458
- Version / Model
- 4033
- Catalog Number
- 4033
- 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
- 0ca0a82e-b53f-4539-b194-b069ab18d10f
Device Description
TERMINAL CAPS
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 |
|---|---|---|---|---|
| 46221 | Pacing/defibrillation lead cap | An implantable device designed to cover and protect the lead terminals of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure, or to isolate (cap) any lead terminals that are not used. 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 | 05414734506458 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K950140 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 23 – 122 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 23 – 122 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 50 Degrees Celsius