FDA UDI
In Commercial Distribution
🇺🇸 United States
Pall Posidyne® NEO Filter
DI: 00636207300935
·
Model: NEO96NY
·
Global Life Sciences Solutions USA LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Pall Posidyne® NEO Filter
- Primary DI
- 00636207300935
- Version / Model
- NEO96NY
- Catalog Number
- NEO96NY
- Company Name
- Global Life Sciences Solutions USA LLC
- Labeler DUNS
- 011658242
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-01
- Public Version
- 6
- Public Version Date
- 2026-02-23
- Public Version Status
- Update
- Public Device Record Key
- 9d2214fd-9ea7-4dd0-b508-5cc07d08ad6f
Device Description
Small volume 0.2 micron Air Eliminating Intravenous Filter for 96 Hour Use with Needle-free Injection Site and ultra-microbore tubing
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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPB | Filter, infusion line | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35072 | Intravenous line filter | A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30636207300936 | GS1 | case | 40 | In Commercial Distribution | |
| Primary | 00636207300935 | GS1 |
Customer Contacts
- Phone
- +1(800)645-6578 ext. 5164843600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K850825 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pore Size | 0.2 | Micrometer |