FDA.reportPublic FDA data

Expandable 15 mm x 5 inch Flex Tube

Primary DI
00636207315458
Brand
Expandable 15 mm x 5 inch Flex Tube
Company
Global Life Sciences Solutions USA LLC
Model
VMFLEX
Catalog number
VMFLEX
Device description
Expandable 15 mm x 5 inch Flex tube, Non-sterile, Single Patient Use
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
30636207315459PackageGS1100In Commercial Distribution
00636207315458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063620731545930636207315459
00636207315458006362073154586362073154580636207315458

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit catheter mount, single-useA device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end; it may include an integrated suction port or be provided with a microbial medical gas filter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch

Contacts#

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

Regulatory Flags#

DUNS number
011658242
Device count
1
DM exempt
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

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