FDA UDI
In Commercial Distribution
🇺🇸 United States
MiniMed® 530G
DI: 00643169507968
·
Model: MMT-751RNAB
·
MEDTRONIC MINIMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MiniMed® 530G
- Primary DI
- 00643169507968
- Version / Model
- MMT-751RNAB
- Company Name
- MEDTRONIC MINIMED, INC.
- Labeler DUNS
- 849626338
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 5
- Public Version Date
- 2023-08-09
- Public Version Status
- Update
- Public Device Record Key
- 95b6ed1d-9b83-4830-9280-f27cce739d8e
Device Description
PUMP MMT-751RNAB PRDGM V3.0 BL US RC
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 Unsafe
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OZO | Artificial pancreas device system, threshold suspend | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64890 | Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm | A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on pre-set thresholds using a dichotomous or binary algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169507968 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P120010 | 005 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius