FDA UDI
In Commercial Distribution
🇺🇸 United States
PLEUR-EVAC
DI: 14026704921871
·
Model: IPN928756
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PLEUR-EVAC
- Primary DI
- 14026704921871
- Version / Model
- IPN928756
- Catalog Number
- A-8002-08LF
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-07
- Public Version
- 1
- Public Version Date
- 2024-02-15
- Public Version Status
- New
- Public Device Record Key
- 4db04b32-c924-465b-9c8d-c641615cb6d8
Device Description
PLEUR-EVAC ADULT-PEDIATRIC WET DUAL COLLECTION 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
- 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 |
|---|---|---|---|---|
| KDQ | BOTTLE, COLLECTION, VACUUM | General Hospital | 880.6740 | 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 |
|---|---|---|---|---|---|---|
| Package | 34026704921875 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 14026704921871 | GS1 | ||||
| Direct Marking | 24026704921878 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905768 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 2.5 | Inch | |
| Total Volume | 2850 | Milliliter | |
| Width | 12.75 | Inch | |
| Length | 16.5 | Inch |