FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ENTERRA® II
DI: 00643169614246
·
Model: 37800
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENTERRA® II
- Primary DI
- 00643169614246
- Version / Model
- 37800
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 796986144
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-11
- Public Version
- 5
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- 2a5c17b9-db38-440a-a105-042f727d09d3
- Distribution End Date
- 2022-10-25
Device Description
INS 37800 ENTERRA II NON-PARYLENE US
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
- 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 |
|---|---|---|---|---|
| LNQ | intestinal Stimulator | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48001 | Gastric electrical stimulation system | An assembly of devices designed to treat chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis through gastric electrical stimulation (GES) of the lower stomach (antrum). The assembly typically includes a battery-powered implantable pulse generator that produces the electrical stimuli delivered via implantable leads, and an external programmer that enables healthcare personnel to telemetrically modify the GES signal parameters of the pulse generator. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169614246 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -34 – 57 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 135 Degrees Fahrenheit