FDA UDI
In Commercial Distribution
🇺🇸 United States
Y-Tube
DI: 14048223016029
·
Model: 001151-37W
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Y-Tube
- Primary DI
- 14048223016029
- Version / Model
- 001151-37W
- Catalog Number
- 001151-37W
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-03-01
- Public Version
- 2
- Public Version Date
- 2021-03-17
- Public Version Status
- Update
- Public Device Record Key
- 0f16aaa1-0700-4663-b1aa-24b6fec97728
- Distribution End Date
- 2025-03-15
Device Description
Y-Tube Injection tube with "Y"-connector to be used with two InfiltraLong
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 |
|---|---|---|---|---|
| BSO | CATHETER, CONDUCTION, ANESTHETIC | Anesthesiology | 868.5120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16858 | Catheter injection port | A device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. It is also intended to be used as a heparin lock by keeping the heparin flush solution in the catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14048223016029 | GS1 | ||||
| Unit of Use | 04048223016022 | GS1 |
Customer Contacts
- Phone
- +1(888)972-5865
- [email protected]