FDA UDI
In Commercial Distribution
🇺🇸 United States
PLEUR-EVAC
DI: 14026704921796
·
Model: IPN928748
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PLEUR-EVAC
- Primary DI
- 14026704921796
- Version / Model
- IPN928748
- Catalog Number
- S-1150-08LF
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-31
- Public Version
- 1
- Public Version Date
- 2024-02-08
- Public Version Status
- New
- Public Device Record Key
- d3311d31-d426-4d52-a67d-7a58cf03873c
Device Description
PLEUR-EVAC SAHARA DRY SUCTION/SEAL CONTINUOUS RE-INFUSION LATEX FREE
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
- No
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| CAC | Apparatus, autotransfusion | Anesthesiology | 868.5830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47797 | Pleural/peritoneal drainage catheterization kit | A collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 34026704921790 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 14026704921796 | GS1 | ||||
| Direct Marking | 24026704921793 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 3.5 | Inch | |
| Width | 11.25 | Inch | |
| Height | 10.5 | Inch | |
| Device Size Text, specify | Dry / Dry |