FDA UDI
In Commercial Distribution
🇺🇸 United States
i-port ADVANCE™
DI: 05705244014183
·
Model: MMT-101T
·
Unomedical A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- i-port ADVANCE™
- Primary DI
- 05705244014183
- Version / Model
- MMT-101T
- Company Name
- Unomedical A/S
- Labeler DUNS
- 306032491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2017-03-31
- Public Version
- 4
- Public Version Date
- 2021-04-12
- Public Version Status
- Update
- Public Device Record Key
- a24c468a-adcc-44b9-a51f-2fab924f64c2
Device Description
Single use injection port for subcutaneous injection. The injection port must be used as described in the Instruction for Use.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FOZ | Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17180 | Subcutaneous infusion/injection port needle | A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05705244014190 | GS1 | outer box | 120 | In Commercial Distribution | |
| Primary | 05705244014183 | GS1 | ||||
| Unit of Use | 05705244014206 | GS1 |
Customer Contacts
- Phone
- 1-800-646-4633
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 90 | degree | |
| Depth | 9 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Do not store or leave the device in direct sunlight