FDA.reportPublic FDA data

WavelinQ

Primary DI
00801741182754
Brand
WavelinQ
Company
Bard Peripheral Vascular, Inc.
Model
W04200
Catalog number
W04200
Device description
WavelinQ™ 4F EndoAVF System
Published
2019-02-22
Public version status
Update
Distribution status
Not 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
PQKPercutaneous catheter for creation of an arteriovenous fistula for hemodialysis access

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis AccessCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741182754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741182754008017411827548017411827540801741182754

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
Device count
1
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
10801741234184EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234156EnCor EnCompass™ENCPSCENCPSC2026-02-04
00801741234163EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
10801741234153EnCor EnCompass™ENCPSCENCPSC2026-02-04
10801741234160EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
00801741236167EnCor EnCompass™ENCP10GVLOCENCP10GVLOC2026-02-04
00801741234194EnCor EnCompass™ENCPSTENCPST2026-02-03
00801741234248EnCor EnCompass™ENCPDriverENCPDriver2026-02-03
00801741234262EnCor EnCompass™ENCPFSENCPFS2026-02-03
00801741235221EnCor EnCompass™ENCPConsoleENCPConsole2026-02-03
00801741234095EnCor EnCompass™ENCP7GENCP7G2026-01-30
00801741234132EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
00801741234118EnCor EnCompass™ENCP12GENCP12G2026-01-28
00801741234149EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
00801741234170EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874301785Ellipsys MedicalEllipsys, Inc.PQK2026-06-03
00763000574710Ellipsys Power ControllerAVENU MEDICAL, INC.PQK2021-12-10
00763000496975Ellipsys Vascular Access SystemAVENU MEDICAL, INC.PQK2021-02-08
00763000496982Ellipsys Vascular Access SystemAVENU MEDICAL, INC.PQK2021-02-08
00763000478193Ellipsys Power ControllerAVENU MEDICAL, INC.PQK2021-01-27
00801741189104WavelinQCLEARSTREAM TECHNOLOGIES LIMITEDPQK2019-11-15
B357AMI1001Ellipsys Power ControllerAVENU MEDICAL, INC.PQK2018-10-24
B357AMI6005Ellipsys Vascular Access SystemAVENU MEDICAL, INC.PQK2018-10-24
B357AMI1000Ellipsys Power ControllerAVENU MEDICAL, INC.PQK2018-09-18
B357AMI6050Ellipsys Vascular Access SystemAVENU MEDICAL, INC.PQK2018-09-18
00868260000211WavelinQTVA MEDICAL, INC.PQK2018-08-27