FDA UDI
In Commercial Distribution
🇺🇸 United States
Tita Jet Light
DI: 07640110985465
·
Model: 616.360.8070-HA
·
PFM MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Tita Jet Light
- Primary DI
- 07640110985465
- Version / Model
- 616.360.8070-HA
- Company Name
- PFM MEDICAL INCORPORATED
- Labeler DUNS
- 097736867
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-27
- Public Version
- 1
- Public Version Date
- 2020-03-06
- Public Version Status
- New
- Public Device Record Key
- f4315de5-b1f6-43c0-b493-83b860f86122
Device Description
TJL Low Profile HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | General Hospital | 880.5965 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61494 | Vascular port/catheter | A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07640110980835 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 07640110985465 | GS1 |
Customer Contacts
- Phone
- 7607588749
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072481 | 000 |