FDA.reportPublic FDA data

VYGON

Primary DI
03660812125406
Brand
VYGON
Company
VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG
Model
1212.06
Catalog number
00121206
Device description
leaderflex 0.55mmx0.75mmx60mm 22G - 1 lumen catheter set
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FOZCatheter, intravascular, therapeutic, short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33660812125407PackageGS120In Commercial Distribution
53660812125401PackageGS11In Commercial Distribution
03660812125406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3366081212540733660812125407
5366081212540153660812125401
03660812125406036608121254063660812125406

GMDN Terms#

Term, Definition table
TermDefinition
Centrally-inserted central venous catheterA flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
315994731
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03660812138567VYGON1261.3060012613062025-03-20
33660812138568VYGON1261.3060012613062025-03-20
03660812132299VYGON157.1520001571522025-03-15
03660812132305VYGON157.2520001572522025-03-15
03660812133074VYGON8158.1720081581722025-03-15
03660812134224VYGON6155.2720061552722025-03-15
33660812132290VYGON157.1520001571522025-03-15
33660812132306VYGON157.2520001572522025-03-15
53660812133079VYGON8158.1720081581722025-03-15
53660812134229VYGON6155.2720061552722025-03-15
03660812151597VYGON2184.0050021840052023-08-29
03660812151603VYGON2184.0150021840152023-08-29
03660812125390VYGON1212.04001212042023-08-29
53660812151592VYGON2184.0050021840052023-08-29
33660812151604VYGON2184.0150021840152023-08-29
03660812125437VYGON1212.08001212082023-07-24
03660812125475VYGON1212.20001212202023-07-24
53660812125401VYGON1212.06001212062023-07-24
53660812125432VYGON1212.08001212082023-07-24
53660812125470VYGON1212.20001212202023-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902227239ARROWTELEFLEX INCORPORATEDFOZ2026-08-27
10801902222951ARROWTELEFLEX INCORPORATEDFOZ2026-08-19
10801902222968ARROWTELEFLEX INCORPORATEDFOZ2026-08-19
10801902222975ARROWTELEFLEX INCORPORATEDFOZ2026-08-19
10801902226454ARROWTELEFLEX INCORPORATEDFOZ2026-08-10
10801902219210ARROWTELEFLEX INCORPORATEDFOZ2026-08-03
10801902130546ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902218084ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902218404ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902224436ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
00382903935314NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
10801902167344ARROWTELEFLEX INCORPORATEDFOZ2026-07-30
10801902129700ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167351ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167894ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226140ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
10801902226157ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
10801902226164ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
10801902219449ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08