FDA UDI
In Commercial Distribution
🇺🇸 United States
Enlite™ Serter
DI: 00613994933072
·
Model: MMT-7510
·
MEDTRONIC MINIMED, INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Enlite™ Serter
- Primary DI
- 00613994933072
- Version / Model
- MMT-7510
- Company Name
- MEDTRONIC MINIMED, INC.
- Labeler DUNS
- 849626338
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c21c4535-bc83-44db-8f8d-8f343f14ab0a
Device Description
LANCET DEVICE MMT-7510 SNSRTR ENLT 23L
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
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OZO | Artificial pancreas device system, threshold suspend | Unknown | 3 | |
| MDS | Sensor, glucose, invasive | Unknown | 3 | |
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
| OYC | Pump, infusion, insulin, to be used with invasive glucose sensor | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45449 | Injector reset device | A device designed to be used by a layperson (this usually being the recipient of the injection) to reset the loaded position of an injector in a safe and controlled manner. It will typically be designed like a small box or container and have a hinged lid. The injector is placed inside this device and when the lid is closed an internal mechanism resets the injector to its firing position. The injector is removed from this device, the medication is inserted (typically a prefilled syringe or cartridge) and it is ready for use by the user. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613994933072 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P120010 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity