FDA.report

Centurion

Primary DI
10653160349907
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
MCT80L
Catalog number
MCT80L
Device description
CONTAM SHIELD FOR AVA HF, 80CM
Published
2021-12-31
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

Related Records

Contact Domains

Product Codes

CodeName
OFDCatheter introducer kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFDCatheter Introducer KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653160349907PackageGS110In Commercial Distribution
20653160349904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1065316034990710653160349907
2065316034990420653160349904

GMDN Terms

TermDefinition
Peripherally-inserted central venous catheterA thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
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

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