FDA.reportPublic FDA data

Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit

Primary DI
00636207315267
Brand
Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit
Company
Global Life Sciences Solutions USA LLC
Model
VM96DLEX2L
Catalog number
VM96DLEX2L
Device description
"Adult 96"" Expandable Dual Limb Circuit with Removable Limbs, 0.060"" ID CO2 Gas Sampling Line, and 2 Liter Non-Latex Breathing Bag."
Published
2016-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K013093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013093000PALL ULTIPOR ANESTHESIA BREATHING SYSTEMPall Medical2002-08-01CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30636207315268PackageGS120In Commercial Distribution
00636207315267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063620731526830636207315268
00636207315267006362073152676362073152670636207315267

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, reusableAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length96Inch

Contacts#

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

Regulatory Flags#

DUNS number
011658242
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
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05034480315663Pall QPoint® Disposable Water FilterQJC22A2019-02-04
05034480315670Pall QPoint® Disposable Water FilterQRC22A2019-02-04
15034480300925Pall Lipipor TNA2A Infusion FilterTNA2ATNA2A2026-09-21
15034480315752Pall Lipipor NLF1A Infusion FilterNLF1ANLF1A2026-09-21
15034480315769Pall Lipipor NLF2A Infusion FilterNLF2ANLF2A2026-09-21
15034480315776Pall Lipipor NLF2NTA Infusion FilterNLF2NTANLF2NTA2026-09-21
15034480315882Pall ORO Gas Line FilterORO1HA2022-04-26
00636207300904Pall Posidyne® NEO FilterNEO96NEO962016-06-01
00636207300935Pall Posidyne® NEO FilterNEO96NYNEO96NY2016-06-01
00636207000125Pall Posidyne® ELD FilterELD96NTELD96NT2016-06-01
00636207000231Pall Conserve™ Small Volume HMEBB25ABB25A2016-06-01
00636207000323Pall Posidyne® ELD FilterELD96LLELD96LL2016-06-01
00636207000330Pall Posidyne® ELD FilterELD96LYLELD96LYL2016-06-01
00636207000347Pall Posidyne® ELD FilterELD96LYLSELD96LYLS2016-06-01
00636207000699Pall® Total Nutrient Admixture FilterTNA1TNA12016-06-01
00636207000743Pall Ultipor™ 100 Breathing System FilterBB100ABB100A2016-06-01
00636207300683Pall Ultipor™ 100 Breathing System FilterBB100AFBB100AF2016-06-01
00636207300690Pall Ultipor™ 100 Breathing System FilterBB100APFBB100APF2016-06-01

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10612479284125McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
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