FDA.reportPublic FDA data

GIBECK

Primary DI
14026704927729
Brand
GIBECK
Company
TELEFLEX INCORPORATED
Model
IPN929902
Catalog number
19212
Device description
ISO GARD FILTER S
Published
2025-07-30
Public version status
New
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
K965016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K965016000ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)Gibeck, Inc.1997-12-02CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704927726PackageGS125In Commercial Distribution
34026704927723PackageGS110In Commercial Distribution
14026704927729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670492772624026704927726
3402670492772334026704927723
1402670492772914026704927729

GMDN Terms#

Term, Definition table
TermDefinition
Microbial medical gas filter, single-useA screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902210897ARROWIPN925094ASK-21142-HF52026-08-04
10801902210903ARROWIPN925095ASK-21142-SG22026-08-04
10801902210934ARROWIPN925098ASK-21242-SL12026-08-04
10801902227116ARROWIPNB00557ASK-29903-CFV2026-08-31
10801902227208ARROWIPNB00556ASK-29803-CFV2026-08-31
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
10801902226188ARROWIPNB00349SI-111422026-09-28
10801902226195ARROWIPNB00348SI-112422026-09-28
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902227109ARROWIPNB00297ASK-09601-CF2026-09-03
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
10801902193114ARROWIPN920089CDC-29803-XCN1A2026-07-30
10801902193121ARROWIPN920090CDC-29803-XN1A2026-07-30
10801902193190ARROWIPN920097CDC-29903-XCN1A2026-07-30
10801902193206ARROWIPN920098CDC-29903-XN1A2026-07-30
10801902196184ARROWIPN920629EI-040602026-07-30
10801902196498ARROWIPN920660CDC-21142-XCN1A2026-07-30
10801902196511ARROWIPN920662CDC-21242-XCN1A2026-07-30
10801902196528ARROWIPN920663CDC-21242-XN1A2026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530110086Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-10-27
10885632520341HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-27
10885632520358HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-27
10885632520327HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
10885632520334HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
20885632532129HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
00848530093686Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-10-19
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