FDA UDI
In Commercial Distribution
🇺🇸 United States
SYNCHROMED®II
DI: 00643169984219
·
Model: 8637-20
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SYNCHROMED®II
- Primary DI
- 00643169984219
- Version / Model
- 8637-20
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 796986144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-09
- Public Version
- 2
- Public Version Date
- 2019-08-08
- Public Version Status
- Update
- Public Device Record Key
- b6b39591-2e8c-4e69-9335-b4eb318a6eaf
Device Description
PUMP 8637-20 SYNCHROMED II 20ML DLC US
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46024 | Implantable intrathecal infusion pump, programmable | A battery-powered, programmable, sterile device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) delivers drug doses from its implanted reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. The drug reservoir, usually implanted under the skin of the lower abdomen, is typically connected to a catheter placed into the spinal fluid space. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169984219 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P860004 | 270 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 20.0 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from magnets
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 43 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 110 Degrees Fahrenheit