FDA UDI
In Commercial Distribution
🇺🇸 United States
Pall PharmAssure® 25 mm Hydrophobic Vent Filter
DI: 05034480310125
·
Model: HP2002
·
Pall International Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Pall PharmAssure® 25 mm Hydrophobic Vent Filter
- Primary DI
- 05034480310125
- Version / Model
- HP2002
- Catalog Number
- HP2002
- Company Name
- Pall International Sàrl
- Labeler DUNS
- 485050483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-07-27
- Public Version
- 3
- Public Version Date
- 2018-06-26
- Public Version Status
- Update
- Public Device Record Key
- 3baff37c-19fb-4056-b4db-1bab1c5f7b24
Device Description
25 mm 0.2 micron hydrophobic vent filter
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FMF | Syringe, piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60833 | Hydrophobic Luer filter, sterile | A sterile device intended to be attached to equipment during a medical/surgical procedure and/or to a needle during drug preparation (i.e., vial venting) to prevent the transfer of microbes, particulates and aerosols while allowing passage of air/gas; its use is not dedicated to a specific type of medical equipment. It is a small plastic housing containing a hydrophobic filter with male and female Luer connections (Luer-lock or Luer-slip). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05034480310125 | GS1 | ||||
| Unit of Use | 25034480310129 | GS1 |
Customer Contacts
- Phone
- +1(800)645-6578 ext. 5164843600
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pore Size | 0.2 | Micrometer |