FDA.reportPublic FDA data

ARROW

Primary DI
20801902189169
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN919615
Catalog number
AS-05500-1
Device description
SnapLock(TM) Catheter/Syringe Adapter
Published
2022-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103658000FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERTeleflex, Inc.2012-05-16CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902189169PackageGS120In Commercial Distribution
10801902189162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190218916920801902189169
1080190218916210801902189162

GMDN Terms#

Term, Definition table
TermDefinition
Epidural needle, non-threadedA sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
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
true
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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489490312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAZ2022-08-04
10193489031768MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031775MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031782MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031799MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10381780529071Integra®INTEGRA PAIN MANAGEMENTCAZ2019-10-24
10381780527633Integra®INTEGRA PAIN MANAGEMENTCAZ2019-07-16
10381780527404Integra®INTEGRA PAIN MANAGEMENTCAZ2019-05-13
10381780527015Integra®INTEGRA PAIN MANAGEMENTCAZ2019-03-05
10381780511465Integra®INTEGRA PAIN MANAGEMENTCAZ2019-02-27
10381780511281Integra®INTEGRA PAIN MANAGEMENTCAZ2019-01-18
10381780491316Integra®INTEGRA PAIN MANAGEMENTCAZ2018-08-16
10381780464792Integra®INTEGRA PAIN MANAGEMENTCAZ2018-07-16
10381780429531Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431640Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431657Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431749Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431763Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431770Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780466611Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780486756Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780486763Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780429487Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429494Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429524Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429562Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429586Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429593Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429609Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429616Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20