FDA.reportPublic FDA data

VAMP JR. 7 IN (17 CM)

Primary DI
00690103198232
Brand
VAMP JR. 7 IN (17 CM)
Company
Edwards Lifesciences LLC
Model
VJL0063
Catalog number
VJL0063
Device description
BLOOD MANAGEMENT SYSTEM
Published
2020-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161962000VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC2016-11-28KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50690103198237PackageGS110In Commercial Distribution
00690103198232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010319823750690103198237
00690103198232006901031982326901031982320690103198232

GMDN Terms#

Term, Definition table
TermDefinition
Arterial blood sampling kitA collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DRY PLACE

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06
00690103019810HEART VALVE ACCESSORY1175T1175T302026-04-06
00690103019827HEART VALVE ACCESSORY1175T1175T322026-04-06
00690103019834HEART VALVE ACCESSORY1175T1175T342026-04-06
00690103019841HEART VALVE ACCESSORY1175T1175T362026-04-06
00690103019858HEART VALVE ACCESSORY1175T1175T382026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622157M-CATH MicrocatheterAcrostak (Schweiz) AGKRA2018-05-15
10351688507990MedexICU MEDICAL, INC.KRA2016-12-30
10351688508669MedexICU MEDICAL, INC.KRA2016-12-30
10351688505620MedexICU MEDICAL, INC.KRA2016-12-29
10351688508768MedexICU MEDICAL, INC.KRA2016-10-19
10351688508775MedexICU MEDICAL, INC.KRA2016-10-19
10351688508782MedexICU MEDICAL, INC.KRA2016-10-19
10351688508805MedexICU MEDICAL, INC.KRA2016-10-19
10351688506856MedexICU MEDICAL, INC.KRA2016-10-12
10351688506863MedexICU MEDICAL, INC.KRA2016-10-12
10351688508898MedexICU MEDICAL, INC.KRA2016-10-11
10351688509932MedexICU MEDICAL, INC.KRA2016-10-11
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08714729280736Renegade™ HI-FLO™ KitBOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
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