FDA UDI
In Commercial Distribution
🇺🇸 United States
IV Extension Set 6"
DI: 00850014433130
·
Model: 1
·
DISTRIBUTION UNLIMITED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- IV Extension Set 6"
- Primary DI
- 00850014433130
- Version / Model
- 1
- Catalog Number
- DU2260
- Company Name
- DISTRIBUTION UNLIMITED, LLC
- Labeler DUNS
- 926603486
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-19
- Public Version
- 2
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- a6c645a9-1c53-4132-89ec-8580f3a18bd5
Device Description
are connected to IV catheters to allow a larger distance between the patient and the fluid being administered which is often necessary due to the size and volume of equipment being used at any one time
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
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12170 | Intravenous administration tubing extension set | A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850014433137 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00850014433130 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6 | Inch | |
| Device Size Text, specify | Small Bore |