Ultipor™ Anesthesia Breathing Circuit System - Patient Kit

Primary DI
30636207315299
Brand
Ultipor™ Anesthesia Breathing Circuit System - Patient Kit
Company
PALL CORPORATION
Model
VMPKSA
Catalog number
VMPKSA
Device description
Small Vanilla-Scented Adult Face Mask, Ported Elbow and Ultipor 25 Filter. Non-Conductive, Disposable.
Published
2016-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
30636207315299PackageGS120In Commercial Distribution
00636207315298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063620731529930636207315299
00636207315298006362073152986362073152980636207315298

GMDN Terms#

Term, Definition table
TermDefinition
Patient-end respiratory anaesthesia kitA collection of non-sterile devices intended to create a hygienic connection between a patient’s airway and an anaesthesia breathing circuit. It is primarily intended for use with a reusable breathing circuit and typically includes an anaesthesia mask, a tube/mask breathing circuit connector and a microbial medical gas filter. This is a single-patient reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007036101Pall Ultipor 50U552022-04-20
30636207302435Pall® CellWash/Infusion Bag Set791-03791-032016-06-01
30636207302442Pall® Transfer/Freezing Bag Set791-02791-022016-06-01
30636207302466Pall® Freezing Bag 25 mL with Separable Chamber791-05791-052016-06-01
30636207314681Briostor™ Transfer/Freezing Bag Set791-12791-122016-07-20
30636207315398Ultipor™ Anesthesia Breathing Circuit System - CO2 Monitoring LineCO2GSL060CO2GSL0602016-06-29
30636207315336Gas Sampling Elbow with CapWMPELBOVMPELBO2016-06-29
30636207300905Pall Posidyne® NEO FilterNEO96NEO962016-06-01
30636207300936Pall Posidyne® NEO FilterNEO96NYNEO96NY2016-06-01
30363207000244Pall® Breathing Circuit FilterBB50TBB50T2016-06-01
35034480004056Pall LeukoGuard LGBLGBLGB2015-10-21
30636207000126Pall Posidyne® ELD FilterELD96NTELD96NT2016-06-01
30636207000232Pall Conserve™ Small Volume HMEBB25ABB25A2016-06-01
30636207000324Pall Posidyne® ELD FilterELD96LLELD96LL2016-06-01
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
30636207300691Pall Ultipor™ 100 Breathing System FilterBB100APFBB100APF2016-06-01

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Primary DI, Brand, Company table
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