Latex-free Breathing Bag - 2 Liter VM2LBB20

GUDID 30636207315411

Latex-free Breathing Bag - 2 Liter

PALL CORPORATION

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Primary Device ID30636207315411
NIH Device Record Keye8248cfe-5ec3-4a23-8515-845eeb4c186f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLatex-free Breathing Bag - 2 Liter
Version Model NumberVM2LBB20
Catalog NumberVM2LBB20
Company DUNS002054419
Company NamePALL CORPORATION
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com

Device Dimensions

Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter
Total Volume2 Liter

Device Identifiers

Device Issuing AgencyDevice ID
GS100636207315410 [Primary]
GS130636207315411 [Package]
Contains: 00636207315410
Package: case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, bacterial, breathing-circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-29

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00860007036101 - Pall Ultipor 502022-04-28 Breathing Circuit Filter and Heat and Moisture Exchanger
15034480315868 - Pall Ultipor 502022-04-28 Breathing Circuit Filter and Heat and Moisture Exchanger
30636207302435 - Pall® CellWash/Infusion Bag Set2019-09-23 Two empty transfer bags with two spikes and luer adapter and associated tubing for washing blood and cellular components.
30636207302442 - Pall® Transfer/Freezing Bag Set2019-09-23 Two transfer bags (150 mL and 200 mL) and one 25 mL freezing bag for blood component processing and freezing.
30636207302466 - Pall® Freezing Bag 25 mL with Separable Chamber2019-09-23 25 mL Freezing Bag with Separable Chamber for blood component freezing.
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