FDA UDI
In Commercial Distribution
🇺🇸 United States
SJM™
DI: 05414734022149
·
Model: 401758
·
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SJM™
- Primary DI
- 05414734022149
- Version / Model
- 401758
- Catalog Number
- 401758
- Company Name
- ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
- Labeler DUNS
- 040960379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-06
- Public Version
- 4
- Public Version Date
- 2020-09-21
- Public Version Status
- Update
- Public Device Record Key
- 0bc4cde7-ce7a-4067-a3ed-a19df104e40a
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
- 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 |
|---|---|---|---|---|
| DSA | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47483 | Electrocardiographic lead/catheter adaptor | A small, sterile, connecting device that enables a mechanical union between an in situ cardiac catheter [e.g., an electrophysiology (EP) diagnostic catheter] and an electrocardiograph (ECG) cable/lead for transmission of heart signals to an ECG machine. This device allows the connection of the otherwise incompatible connectors of the cardiac catheter to a standard ECG cable/lead or a cable/lead of different manufacture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15414734022146 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 05414734022149 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2.4 | Meter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dark, dry place. Keep dry and keep away from sunlight.