FDA.reportPublic FDA data

ARROW

Primary DI
10801902121339
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN036259
Catalog number
ST-09870
Device description
TwistLock(TM) Cath-Gard(R) Catheter Contamination Shield for use with 7 Fr. Catheters
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895268000ARROW HANDS-OFF THERMO-PACEArrow Intl., Inc.1989-11-06DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40801902121330PackageGS125In Commercial Distribution
10801902121339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4080190212133040801902121330
1080190212133910801902121339

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-use, sterileA sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. 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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704927910PILLINGIPN0079065068002026-07-08
10801902226171ARROWPR-45552-BASPR-45552-BAS2026-07-06
10841156112035LANGSTONIPN93901955402026-06-26
10801902218732ARROWIPN928981CS-15853-E2026-06-24
10801902221725ARROWIPN930533EC-055002026-06-24
14026704664983HUDSON RCIIPN039676158002026-06-24
14026704664990HUDSON RCIIPN039677158022026-06-24
14026704665003HUDSON RCIIPN039678158042026-06-24
14026704665027HUDSON RCIIPN039680158082026-06-24
14026704665034HUDSON RCIIPN039681158102026-06-24
14026704665164HUDSON RCIIPN03969412712026-06-24
14026704665171HUDSON RCIIPN03969512722026-06-24
14026704665195HUDSON RCIIPN03969712742026-06-24
14026704665201HUDSON RCIIPN03969812752026-06-24
14026704924254PLEUR-EVACIPN929357PE104-082026-06-24
15060112315029LMA AIRWAY MANAGEMENTIPN0487781280302026-06-24
15060112315036LMA AIRWAY MANAGEMENTIPN0487801280402026-06-24
15060112315043LMA AIRWAY MANAGEMENTIPN0487821280502026-06-24
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156112035LANGSTONTELEFLEX INCORPORATEDDQO2026-06-26
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
07290017268316SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268323SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268330SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268361SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268385SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268392SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268408SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268804DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268811DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268828DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268866DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268873DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268880DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268309SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268835DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268842DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268859DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
07290017268002SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268019SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268026SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268033SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10