FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 05414734500029
·
Model: AC-0130
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 05414734500029
- Version / Model
- AC-0130
- Catalog Number
- AC-0130
- 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
- 2024-12-04
- Public Version Status
- Update
- Public Device Record Key
- bbdfa2b7-99d2-4c35-a4ff-849efc94f96e
Device Description
SILICONE OIL
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
- No
- 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 |
|---|---|---|---|---|
| LWS | Implantable cardioverter defibrillator (non-CRT) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46220 | Implantable-device lubricant | A friction-reducing substance (e.g., mineral oil) that is primarily used on implantable devices prior to implantation to lubricate surfaces for the promotion of effective function. It is typically used on the pacing leads of implantable pacemakers/defibrillators to lubricate the lead terminal pin to ease its insertion into the header connector (connection socket) of a pulse generator where it is locked into place (some leads have seal rings on the terminal pin which create friction). It is typically supplied in a small disposable tube. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05414734500029 | GS1 | ||||
| Secondary | H758AC01300 | HIBCC |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius