FDA.reportPublic FDA data

ARROW

Primary DI
14026704736765
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN919607
Catalog number
AK-05000
Device description
TheraCath(R) Epidural Catheterization Kit
Published
2021-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K801912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K801912000ARROW POSITIVE PLACEMENT CON/EPIDURAL ANArrow Intl., Inc.1980-09-16CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704736762PackageGS110In Commercial Distribution
14026704736765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670473676224026704736762
1402670473676514026704736765

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia 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
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
14026704610904LMAIPN046748V1750152018-09-15
14026704610928LMAIPN046750V1750252018-09-15
14026704640277RUSCHIPN0499450044511002019-04-23
14026704641779RUSCHIPN0499380044311002019-04-24
14026704641793RUSCHIPN0499410044335002019-04-24
14026704641816RUSCHIPN0499430044490002019-04-24
14026704641823RUSCHIPN0499440044500502019-04-24
05060112311918LMAIPN046959V1250302018-09-15
10801902226119ARROWPR-45563-BASPR-45563-BAS2026-10-07
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
10801902225907ARROWPR-45541-BASPR-45541-BAS2026-10-06
10801902226188ARROWIPNB00349SI-111422026-09-28
10801902226195ARROWIPNB00348SI-112422026-09-28
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193493001088SINGLE SHOT EPIDURAL TRAYAvanos Medical, Inc.CAZ2026-08-21
10801902209471ARROWTELEFLEX INCORPORATEDCAZ2026-07-29
10801902217193ARROWTELEFLEX INCORPORATEDCAZ2026-07-29
15019517332063PortexICU MEDICAL, INC.CAZ2026-07-27
10801902202243ARROWTELEFLEX INCORPORATEDCAZ2026-07-13
04048223070116UniPlex® NanoLine®Pajunk GmbH MedizintechnologieCAZ2026-06-10
04048223073056EpiLong CathPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223074787EpiSpin Safety NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223074800EpiSpin Safety NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223084182EpiLong NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088005SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088050PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088661SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088692SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088708PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088722PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223089873LOR NRFit 10ml, SlipPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223090466EpiLong CathPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223125267SonoLong SoftSecurePajunk GmbH MedizintechnologieCAZ2026-06-10
10801902216486ARROWTELEFLEX INCORPORATEDCAZ2023-10-26
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
04048223116869PLEXOLONGPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223116883PLEXOLONGPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117088STIMULONG SONOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117187PLEXOLONG NANOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117309SONOLONG ECHOPajunk GmbH MedizintechnologieCAZ2021-07-07