FDA UDI
In Commercial Distribution
🇺🇸 United States
PLEUR-EVAC
DI: 14026704631213
·
Model: IPN028440
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- PLEUR-EVAC
- Primary DI
- 14026704631213
- Version / Model
- IPN028440
- Catalog Number
- A-1500-08LF
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-12
- Public Version
- 6
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- 4edb0add-2b90-45a4-a119-1c047c21b891
Device Description
PLEUR-EVAC AUTOTRANSFUSION BAG 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 |
|---|---|---|---|---|
| 63652 | Thoracic suction collection container | A device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates three graduated chambers, designed for fluid collection, water seal, and suction control, and a suction regulator, air leak indicator, and connection tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 24026704631210 | GS1 | ||||
| Package | 34026704631217 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 14026704631213 | GS1 | ||||
| Previous | 04026704428779 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Autotransfusion Bags | ||
| Width | 5.5 | Inch | |
| Depth | 2.5 | Inch | |
| Height | 11 | Inch |