FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PleuraFlow® POD
DI: 00856449006130
·
Model: PFPD-7515
·
Clearflow, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PleuraFlow® POD
- Primary DI
- 00856449006130
- Version / Model
- PFPD-7515
- Company Name
- Clearflow, Inc.
- Labeler DUNS
- 827428223
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-01
- Public Version
- 5
- Public Version Date
- 2023-05-26
- Public Version Status
- Update
- Public Device Record Key
- a065e57f-2236-4221-9422-d2c80204b289
- Distribution End Date
- 2021-04-30
Device Description
High Capacity Dry Thoracic Drainage Pod-2400 mL Dual Chamber
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
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 | 10856449006137 | GS1 | Box | 5 | Not in Commercial Distribution | 2021-04-30 |
| Primary | 00856449006130 | GS1 |
Customer Contacts
- Phone
- 844-257-3569
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature, humidity and ultraviolet light