Pall Ultipor 50

Primary DI
15034480315868
Brand
Pall Ultipor 50
Company
Global Life Sciences Solutions USA LLC
Model
U55N
Device description
Breathing Circuit Filter and Heat and Moisture Exchanger
Published
2022-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211286000Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture ExchangerPall Corporation2021-11-16CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15034480315868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1503448031586815034480315868

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger/microbial medical gas filterA device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
011658242
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00636207300904Pall Posidyne® NEO FilterNEO96NEO962016-06-01
00636207300935Pall Posidyne® NEO FilterNEO96NYNEO96NY2016-06-01
00636207000125Pall Posidyne® ELD FilterELD96NTELD96NT2016-06-01
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00636207000323Pall Posidyne® ELD FilterELD96LLELD96LL2016-06-01
00636207000330Pall Posidyne® ELD FilterELD96LYLELD96LYL2016-06-01
00636207000347Pall Posidyne® ELD FilterELD96LYLSELD96LYLS2016-06-01
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00636207000743Pall Ultipor™ 100 Breathing System FilterBB100ABB100A2016-06-01
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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

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