FDA.reportPublic FDA data

Pall Supor® AEF Filter

Primary DI
05034480308825
Brand
Pall Supor® AEF Filter
Company
Pall International Sàrl
Model
AEF1NTE
Catalog number
AEF1NTE
Device description
0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use. Without attached extension tubing.
Published
2016-07-20
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
K993379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993379000PALL SUPOR AEF FILTERPall Corp.1999-12-16FPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35034480308826PackageGS150In Commercial Distribution
05034480308825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3503448030882635034480308826
05034480308825050344803088255034480308825

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

Contacts#

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

Regulatory Flags#

DUNS number
485050483
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05034480310125Pall PharmAssure® 25 mm Hydrophobic Vent FilterHP2002HP20022016-07-27
05034480000392Pall LeukoGuard LGLG6LG62015-10-21
05034480000408Pall LeukoGuard LGLG6BLG6B2015-10-21
05034480000446Pall® Oxygenator Gas Line FilterORO1HORO1H2016-07-20
05034480104373Pall Supor® AEF FilterAEF1EAEF1E2016-07-20
05034480306104Pall LeukoGuard BC2BC2BBC2B2015-10-21
05034480308979Pall LaparoShield® Plus Laparoscopic Smoke Filtration SystemLSF1LSF12016-07-20
05034480309143Pall® Pro-Tec Filter for Pulmonary Function TestingPF30SPF30S2016-07-20
05034480310170Pall PharmAssure® Syringe FilterHP4648HP46482024-03-15
05034480313553Pall-Aquasafe™ Water FilterAQF4AAQF4A2016-07-20
05034480313690Pall-Aquasafe™ Water FilterAQ31F1SAAQ31F1SA2016-07-20
05034480313744Pall-Aquasafe™ Water FilterAQ31F1RAAQ31F1RA2016-07-20
05034480313751Pall-Aquasafe™ Water FilterAQINAAQINA2016-07-20
05034480314147Pall LaparoShield® Plus Laparoscopic Smoke FilterLSF2LSF22016-07-20
05034480314802Pall-Aquasafe™ Detachable Shower RoseAQROSEAAQROSEA2016-07-20
05034480315106Pall625418562541852015-10-21
05034480315502Pall QPoint® Filter CapsuleQJ22AQJ22A2017-12-20
05034480315519Pall QPoint® Filter CapsuleQJ212AQJ212A2017-12-20
05034480315526Pall QPoint® Filter CapsuleQR212AQR212A2017-12-20
05034480315533Pall QPoint® Filter CapsuleQR22AQR22A2017-12-20

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Primary DI, Brand, Company table
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