FDA UDI
In Commercial Distribution
🇺🇸 United States
Jet-Vac Procedure Trays
DI: 00813623015531
·
Model: M7514
·
PFM MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Jet-Vac Procedure Trays
- Primary DI
- 00813623015531
- Version / Model
- M7514
- Catalog Number
- M7514
- Company Name
- PFM MEDICAL INCORPORATED
- Labeler DUNS
- 097736867
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-02
- Public Version
- 3
- Public Version Date
- 2019-09-06
- Public Version Status
- Update
- Public Device Record Key
- fa8ddfa9-7581-4449-b3d1-ddadee673a2c
Device Description
5F x 10cm Jet-Vac Centesis Catheter
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
- Yes
- 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 |
|---|---|---|---|---|
| GCB | Needle, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40601 | Peripheral vascular catheter | A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20813623015535 | GS1 | 20 | In Commercial Distribution | ||
| Package | 10813623015538 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00813623015531 | GS1 |
Customer Contacts
- Phone
- 7607588749
- [email protected]