FDA UDI
In Commercial Distribution
🇺🇸 United States
insuflon™
DI: 05705244004030
·
Model: 98-000-2612
·
Unomedical A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- insuflon™
- Primary DI
- 05705244004030
- Version / Model
- 98-000-2612
- Company Name
- Unomedical A/S
- Labeler DUNS
- 306032491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 3
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- a5e13f34-bda6-44ea-a992-68628da0cfd1
Device Description
Single use indwelling catheter for multiple subcutaneous injections. The indwelling catheter 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
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 05705244004030 | GS1 | ||||
| Unit of Use | 05705244013414 | GS1 | ||||
| Package | 05705244004047 | GS1 | Outer box | 200 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 27 | Gauge | |
| Angle | 30 | degree |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from direct sunlight. Store at room temperature.