FDA.report

VYGON

Primary DI
38498840005331
Brand
VYGON
Company
Vygon Corporation
Model
AMS-9538CP
Catalog number
AMS-9538CP
Device description
PORT/PICC ACCESS KIT
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OWLPeripheral catheter insertion kit

Product Code Classifications

CodeDeviceSpecialtyClass
OWLPeripheral Catheter Insertion KitGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
38498840005331PackageGS150In Commercial Distribution
08498840005330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3849884000533138498840005331
08498840005330084988400053308498840005330

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
120818216
Device count
1
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
false
Sterilization required before use
false

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