Pall Ultipor 50

Primary DI
00860007036101
Brand
Pall Ultipor 50
Company
PALL CORPORATION
Model
U55
Device description
Breathing Circuit Filter and Heat and Moisture Exchanger
Published
2022-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
20860007036105PackageGS150In Commercial Distribution
00860007036101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086000703610520860007036105
00860007036101008600070361018600070361010860007036101

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

Other Devices From This Company#

Primary DI, Brand, Model table
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30636207000331Pall Posidyne® ELD FilterELD96LYLELD96LYL2016-06-01
30636207000348Pall Posidyne® ELD FilterELD96LYLSELD96LYLS2016-06-01
30636207000690Pall® Total Nutrient Admixture FilterTNA1TNA12016-06-01
30636207000744Pall Ultipor™ 100 Breathing System FilterBB100ABB100A2016-06-01
30636207300684Pall Ultipor™ 100 Breathing System FilterBB100AFBB100AF2016-06-01
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30636207301193Pall Posidyne® ELD FilterELD96NYSELD96NYS2016-06-01

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