FDA.reportPublic FDA data

NA

Primary DI
04046964715631
Brand
NA
Company
B. BRAUN MEDICAL INC.
Model
610403
Catalog number
610403
Device description
AYC013 SGL Y TD PLASTIC TOOL
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
DQXWIRE, GUIDE, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964715631PrimaryGS10
04046964715624Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964715631040469647156314046964715631
04046964715624040469647156244046964715624

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
5
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
false
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
04046955672370Design Options®5606805606802026-05-24
04046955850839Omnifix®4616025V-024616025V-022026-03-08
04046955897186Design Options®5703495703492026-03-02
04045928020866Design Options®5521505521502026-02-03
04046955900534Perifix®5520475520472026-02-03
04046955900855Design Options®5555255555252026-02-03
04046955901197Combined Spinal & Epidural5301535301532026-02-03
04045928020200Design Options®5301855301852020-04-24
04046955966165Design Options®5703605703602026-01-25
04046955086832Extension Set4904964904962017-10-28
04046964296710Extension Set4565214565212016-09-23
04046964525728Extension Set4903164903162016-09-23
04046964296697Extension Set4565204565202016-09-23
04046964183218Perifix®4150004150002016-09-23
04046964941054PERIFIX™3391603391602016-10-24
04046964332333VENA TECH6107716107712017-01-18
04046955672028Design Options®5606765606762025-12-22
04046955745753Introcan Safety ® 24242001-024242001-022025-12-19
04046955745838Introcan Safety ® 24242003-024242003-022025-12-19
04046955745913Introcan Safety ® 24242005-024242005-022025-12-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10816349013581GuideRightLake Region MedicalDQX2026-03-24
10816349013598GuideRightLake Region MedicalDQX2026-03-24
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10816349013611GuideRightLake Region MedicalDQX2026-03-24
10816349013628GuideRightLake Region MedicalDQX2026-03-24
10816349013635GuideRightLake Region MedicalDQX2026-03-24
10816349013642GuideRightLake Region MedicalDQX2026-03-24
10816349013659GuideRightLake Region MedicalDQX2026-03-24
10816349013666GuideRightLake Region MedicalDQX2026-03-24
10884450529581SplashWire™Merit Medical Systems, Inc.DQX2026-03-24
20801902193418ARROWTELEFLEX INCORPORATEDDQX2026-03-23
20801902221876ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221883ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221890ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902225522ARROWTELEFLEX INCORPORATEDDQX2026-03-11
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