Pall Posidyne® NEO Filter

Primary DI
00636207300904
Brand
Pall Posidyne® NEO Filter
Company
Global Life Sciences Solutions USA LLC
Model
NEO96
Catalog number
NEO96
Device description
Small volume 0.2 micron Air Eliminating Intravenous Filter for 96 Hour Use
Published
2016-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPBFilter, infusion line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPBFilter, Infusion LineGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850825000AEF POSIDYNE I.V. FILTER/AIR ELIMINATORPall Biomedical Products Co.1985-04-09FPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30636207300905PackageGS150In Commercial Distribution
00636207300904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063620730090530636207300905
00636207300904006362073009046362073009040636207300904

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line filterA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pore Size0.2Micrometer

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)645-6578QAMedical@pall.com

Regulatory Flags#

DUNS number
011658242
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636207300935Pall Posidyne® NEO FilterNEO96NYNEO96NY2016-06-01
00636207000125Pall Posidyne® ELD FilterELD96NTELD96NT2016-06-01
00636207000231Pall Conserve™ Small Volume HMEBB25ABB25A2016-06-01
00636207000323Pall Posidyne® ELD FilterELD96LLELD96LL2016-06-01
00636207000330Pall Posidyne® ELD FilterELD96LYLELD96LYL2016-06-01
00636207000347Pall Posidyne® ELD FilterELD96LYLSELD96LYLS2016-06-01
00636207000699Pall® Total Nutrient Admixture FilterTNA1TNA12016-06-01
00636207000743Pall Ultipor™ 100 Breathing System FilterBB100ABB100A2016-06-01
00636207300683Pall Ultipor™ 100 Breathing System FilterBB100AFBB100AF2016-06-01
00636207300690Pall Ultipor™ 100 Breathing System FilterBB100APFBB100APF2016-06-01
00636207301192Pall Posidyne® ELD FilterELD96NYSELD96NYS2016-06-01
00636207302434Pall® CellWash/Infusion Bag Set791-03791-032016-06-01
00636207302441Pall® Transfer/Freezing Bag Set791-02791-022016-06-01
00636207302465Pall® Freezing Bag 25 mL with Separable Chamber791-05791-052016-06-01
00636207302984Ultipor™ 25 Anesthesia Breathing Circuit System FilterBB25ABBB25AB2016-06-29
00636207305466Ultipor™ 25 Anesthesia Breathing Circuit System FilterBB25ABNBB25ABN2016-06-29
00636207311290Pall® Heat and Moisture ExchangerHME40HME402016-06-01
00636207314680Briostor™ Transfer/Freezing Bag Set791-12791-122016-07-20
00636207315182Ultipor™ Anesthesia Breathing Circuit System - Adult Machine KitVM40DLNEXVM40DLNEX2016-06-29
00636207315199Ultipor™ Anesthesia Breathing Circuit System - Adult Machine KitVM40COAXVM40COAX2016-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
46975124930965 Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.FPB2026-04-11
00859695006084WalkMed InfusionWALKMED TECHNOLOGIES, LLCFPB2025-09-12
00849884006179VYGONVygon CorporationFPB2023-06-05
00849884006186VYGONVygon CorporationFPB2023-06-05
30849884006170VYGONVygon CorporationFPB2023-06-05
30849884006187VYGONVygon CorporationFPB2023-06-05
08426314391399GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391412GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391474GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391481GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
28426314391416GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
00849884005035VYGONVygon CorporationFPB2021-01-22
00849884005042VYGONVygon CorporationFPB2021-01-22
30849884005036VYGONVygon CorporationFPB2021-01-22
30849884005043VYGONVygon CorporationFPB2021-01-22
00085412639338EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-10-21
00085412639444FLUID SYSTEMS ACCESSORIESBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
00085412653297EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
00085412660387EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
50085412639449FLUID SYSTEMS ACCESSORIESBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
10849884002604VYGONVygon CorporationFPB2020-04-01
30849884002608VYGONVygon CorporationFPB2020-04-01
00849884004328VYGONVygon CorporationFPB2020-01-27
30849884004329VYGONVygon CorporationFPB2020-01-27
00849884000337VYGONVygon CorporationFPB2019-12-16
30849884000338VYGONVygon CorporationFPB2019-12-16
00849884000504VYGONVygon CorporationFPB2019-11-14
30849884000505VYGONVygon CorporationFPB2019-11-14
00849884002775VYGONVygon CorporationFPB2019-11-01
30849884002776VYGONVygon CorporationFPB2019-11-01