FDA UDI
In Commercial Distribution
🇺🇸 United States
Y-Tube
DI: 04048223131077
·
Model: 001151-37W
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Y-Tube
- Primary DI
- 04048223131077
- 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
- 1
- Record Status
- Published
- Publish Date
- 2025-11-04
- Public Version
- 1
- Public Version Date
- 2025-11-12
- Public Version Status
- New
- Public Device Record Key
- fb112686-1e82-4323-9960-e41b9e5ced9d
Device Description
Y-Tube Injection tube with "Y"-connector to be used with two InfiltraLong
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
- 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 |
|---|---|---|---|---|
| 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. Some types may be designed as a Y-connector with an additional inlet (e.g., with a female Luer connection point) to facilitate sequential injection and infusion of fluids (e.g., medication followed by saline). It may be additionally intended for use as a heparin/saline lock by keeping the 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 |
|---|---|---|---|---|---|---|
| Package | 04048223132456 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04048223131077 | GS1 | ||||
| Previous | 04048223048900 | GS1 |
Customer Contacts
- Phone
- +1 770-493-6832
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080675 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 65 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius