FDA.reportPublic FDA data

VYGON

Primary DI
53660812125432
Brand
VYGON
Company
VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG
Model
1212.08
Catalog number
00121208
Device description
leaderflex 0.55mmx0.75mmx80mm 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
OTC
false
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
33660812125438PackageGS120In Commercial Distribution
53660812125432PackageGS11In Commercial Distribution
03660812125437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3366081212543833660812125438
5366081212543253660812125432
03660812125437036608121254373660812125437

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315994731
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

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
03660812125406VYGON1212.06001212062023-07-24
03660812125437VYGON1212.08001212082023-07-24
03660812125475VYGON1212.20001212202023-07-24
53660812125401VYGON1212.06001212062023-07-24
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