FDA.reportPublic FDA data

Pall® Total Nutrient Admixture Filter

Primary DI
30636207000690
Brand
Pall® Total Nutrient Admixture Filter
Company
PALL CORPORATION
Model
TNA1
Catalog number
TNA1
Device description
1.2 micron Total Nutrient Admixture Filter with Non-Phthalate Fluid Pathway
Published
2016-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K905794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905794000PALL 3N1 FILTERPall Biomedical Products Co.1991-06-13FPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30636207000690PackageGS140In Commercial Distribution
00636207000699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063620700069030636207000690
00636207000699006362070006996362070006990636207000699

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pore Size1.2Micrometer

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
002054419
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007036101Pall Ultipor 50U552022-04-20
30636207302435Pall® CellWash/Infusion Bag Set791-03791-032016-06-01
30636207302442Pall® Transfer/Freezing Bag Set791-02791-022016-06-01
30636207302466Pall® Freezing Bag 25 mL with Separable Chamber791-05791-052016-06-01
30636207314681Briostor™ Transfer/Freezing Bag Set791-12791-122016-07-20
30636207315398Ultipor™ Anesthesia Breathing Circuit System - CO2 Monitoring LineCO2GSL060CO2GSL0602016-06-29
30636207315336Gas Sampling Elbow with CapWMPELBOVMPELBO2016-06-29
30636207300905Pall Posidyne® NEO FilterNEO96NEO962016-06-01
30636207300936Pall Posidyne® NEO FilterNEO96NYNEO96NY2016-06-01
30363207000244Pall® Breathing Circuit FilterBB50TBB50T2016-06-01
35034480004056Pall LeukoGuard LGBLGBLGB2015-10-21
30636207000126Pall Posidyne® ELD FilterELD96NTELD96NT2016-06-01
30636207000232Pall Conserve™ Small Volume HMEBB25ABB25A2016-06-01
30636207000324Pall Posidyne® ELD FilterELD96LLELD96LL2016-06-01
30636207000331Pall Posidyne® ELD FilterELD96LYLELD96LYL2016-06-01
30636207000348Pall Posidyne® ELD FilterELD96LYLSELD96LYLS2016-06-01
30636207000744Pall Ultipor™ 100 Breathing System FilterBB100ABB100A2016-06-01
30636207300684Pall Ultipor™ 100 Breathing System FilterBB100AFBB100AF2016-06-01
30636207300691Pall Ultipor™ 100 Breathing System FilterBB100APFBB100APF2016-06-01
30636207301193Pall Posidyne® ELD FilterELD96NYSELD96NYS2016-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15034480300925Pall Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
15034480315752Pall Lipipor NLF1A Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
15034480315769Pall Lipipor NLF2A Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
15034480315776Pall Lipipor NLF2NTA Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
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