FDA UDI
In Commercial Distribution
🇺🇸 United States
PLEUR-EVAC
DI: 04026704428786
·
Model: IPN010573
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PLEUR-EVAC
- Primary DI
- 04026704428786
- Version / Model
- IPN010573
- Catalog Number
- A-4301-08LF
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 1e5262c5-f83e-4c3e-ae5d-54e2e78ec910
Device Description
PE PNEUMONECTOMY LF
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
- 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 |
|---|---|---|---|---|
| 10817 | Pleural drainage system | An assembly of sterile devices intended to be used for the aspiration of air/fluid from the pleural cavity (potential space between the serous membranes covering the lungs) by means of suction. It includes a pleural catheter, a water seal (underwater) drainage unit, typically with three separate chambers, and typically a suction system regulator, intended to be connected to the hospital's central vacuum system; it does not include pharmaceuticals. This system is usually used to restore normal lung function following chest or mediastinal surgery (e.g., open heart surgery), or to treat conditions such as pneumothorax and/or haemothorax. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704428780 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 04026704428786 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Pneumonectomy Drain | ||
| Width | 13 | Inch | |
| Height | 18 | Inch | |
| Depth | 2.5 | Inch |