Pall Posidyne® ELD Filter

Primary DI
00636207301192
Brand
Pall Posidyne® ELD Filter
Company
Global Life Sciences Solutions USA LLC
Model
ELD96NYS
Catalog number
ELD96NYS
Device description
0.2 micron Intravenous Filter for 96 Hour Use with Standard bore Extension Tubing and Needleless Y Injection Site
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
30636207301193PackageGS148In Commercial Distribution
00636207301192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063620730119330636207301193
00636207301192006362073011926362073011920636207301192

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

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Primary DI, Brand, Model table
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