FDA.reportPublic FDA data

ARROW

Primary DI
00801902100504
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN033130
Catalog number
EG-04900
Device description
Arrow-Johans(TM) ECG Adapter for Right Atrial Electrocardiography (RAECG)
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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862056000[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPArrow Intl., Inc.1986-08-25DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902100508PackageGS125Not in Commercial Distribution
30801902100505PackageGS12Not in Commercial Distribution
00801902100504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2080190210050820801902100508
3080190210050530801902100505
00801902100504008019021005048019021005040801902100504

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead switching adaptorA switching device to which electrocardiograph (ECG) limb and chest leads may be attached. It is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations (e.g., leads I, II and III). This device will typically be used when the devices to be connected are from different manufacturer's, enabling them to mate together. This is a reusable 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

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

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Primary DI, Brand, Company table
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07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
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