FDA.reportPublic FDA data

Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit

Primary DI
00636207315199
Brand
Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit
Company
Global Life Sciences Solutions USA LLC
Model
VM40COAX
Catalog number
VM40COAX
Device description
"Adult 40"" Uni-Limb (Coaxial) Circuit with Expiratory Tubing attached @ 3-Way Inspiratory Port, 0.060"" ID CO2 Gas Sampling Line, and 3 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
30636207315190PackageGS120In Commercial Distribution
00636207315199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063620731519030636207315190
00636207315199006362073151996362073151990636207315199

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
Length40Inch

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00636207301192Pall Posidyne® ELD FilterELD96NYSELD96NYS2016-06-01
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

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