FDA.reportPublic FDA data

Seamless™

Primary DI
04046955065318
Brand
Seamless™
Company
B. BRAUN MEDICAL INC.
Model
655402
Catalog number
655402
Device description
4F MIK 4CM NDL-018 NT GW W TIP-STIF
Published
2017-07-02
Public version status
Update
Distribution status
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
OFLPercutaneous sheath introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFLPercutaneous Sheath Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955065318PrimaryGS10
04046955065301Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955065318040469550653184046955065318
04046955065301040469550653014046955065301

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor microcatheter for access into superselective small vessels. This is a single-use device.

Device Sizes#

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

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
10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841268110059Micro-Introducer KitGALT MEDICAL CORP.OFL2026-01-19
10841268110097TVS LPAGALT MEDICAL CORP.OFL2026-01-19
10841268110127TVS LPAGALT MEDICAL CORP.OFL2026-01-19
10841268110349Micro-Introducer KitGALT MEDICAL CORP.OFL2026-01-19
10841268110387Micro-Introducer KitGALT MEDICAL CORP.OFL2026-01-19
10810050855805Typenex Introducer SetTYPENEX MEDICAL LLCOFL2025-11-17
H965459001Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459011Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459021Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459151Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459161Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459171Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459181Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
20886333227550ClosureFast Micro Puncture ARGON MEDICAL DEVICES, INC.OFL2024-07-29
20886333227567ClosureFast Micro PunctureARGON MEDICAL DEVICES, INC.OFL2024-07-29
50197106004058CARDINAL HEALTHCardinal Health 200, LLCOFL2022-10-27
10841268109800Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109817Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109824Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109831Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109848Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109855Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109862Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109879Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109886Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109893Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109909Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109916Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109923Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109930Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15