FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EXEL SecureTouch Safety Huber Infusion Set
DI: 10020221378419
·
Model: 37841
·
Exel International
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- EXEL SecureTouch Safety Huber Infusion Set
- Primary DI
- 10020221378419
- Version / Model
- 37841
- Catalog Number
- 37841
- Company Name
- Exel International
- Labeler DUNS
- 180572216
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2023-04-21
- Public Version Status
- Update
- Public Device Record Key
- 6c1c3c78-90ea-4a22-941c-a300e8d8f160
- Distribution End Date
- 2023-04-20
Device Description
Safety Huber Infusion Set, non-coring, 19G X 3/4, with Y injection site, 7"tube
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
- 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 |
|---|---|---|---|---|
| 17701 | Vascular port administration set | A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30020221378413 | GS1 | 8 | Not in Commercial Distribution | 2023-04-20 | |
| Primary | 10020221378419 | GS1 | ||||
| Unit of Use | 00020221378412 | GS1 |