FDA.reportPublic FDA data

Ultipor™ Anesthesia Breathing Circuit System - CO2 Monitoring Line

Primary DI
30636207315398
Brand
Ultipor™ Anesthesia Breathing Circuit System - CO2 Monitoring Line
Company
PALL CORPORATION
Model
CO2GSL060
Catalog number
CO2GSL060
Device description
3 Meter CO2 Monitoring Line (0.060” ID) 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
30636207315398PackageGS1100In Commercial Distribution
00636207315397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063620731539830636207315398
00636207315397006362073153976362073153970636207315397

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible tube(s) primarily intended to be used as an interface between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor]. It may be intended for pressure and flow monitoring and/or gas sampling, but does not include any components intended for delivery of medical gas to the patient; a microbial filter may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Meter

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
false
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
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
30636207301193Pall Posidyne® ELD FilterELD96NYSELD96NYS2016-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B462100053363PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
B462100053393PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
10612479284002McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284026McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284040McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284064McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284101McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284125McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
14026704927736GIBECKTELEFLEX INCORPORATEDCAH2026-08-01
14026704928993GIBECKTELEFLEX INCORPORATEDCAH2026-07-28
00817081028683PFT KIT F, VBMax 35e Filter KitA-M SYSTEMS, LLCCAH2026-07-17
00817081028669PFT Kit J, 31s VBMax Filter with Blue Foam Nose ClipA-M SYSTEMS, LLCCAH2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-06-23
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
00848530089115Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089139Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089108Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530093839Cough Assist KitSunset Healthcare Solutions, Inc.CAH2025-05-21
00848530099503Bacteria FilterSunset Healthcare Solutions, Inc.CAH2025-05-15
00848530092283Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-15
00848530104511Oxygen FilterSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530104689Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530105372Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530105389Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
008485301044366IN HEPA Capsule with Removable StickerSunset Healthcare Solutions, Inc.CAH2025-05-13
00848530104863Bacteria FilterSunset Healthcare Solutions, Inc.CAH2025-05-13
00848530104672Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-04-21