FDA UDI
In Commercial Distribution
🇺🇸 United States
Medtronic MiniMed Pro-Set Infusion Set, PCAP Connection 24in
DI: 00382903286164
·
Model: 328616
·
Becton, Dickinson and Company Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
150
Basic Information
- Brand Name
- Medtronic MiniMed Pro-Set Infusion Set, PCAP Connection 24in
- Primary DI
- 00382903286164
- Version / Model
- 328616
- Catalog Number
- 328616
- Company Name
- Becton, Dickinson and Company Inc
- Labeler DUNS
- 047047543
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2016-08-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 83c1a14a-7cd8-4194-96e1-cc28f1b89d9f
Device Description
MINIMED 24IN PCAP MMT-280600
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50382903286169 | GS1 | Case | 15 | In Commercial Distribution | |
| Primary | 00382903286164 | GS1 | ||||
| Unit of Use | 00382903673247 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160651 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24 | Inch |