FDA.report

Medline Industries, Inc.

Primary DI
00653160339239
Brand
Medline Industries, Inc.
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
ECVC7095
Catalog number
ECVC7095
Device description
MULTI-LUMEN CENTRAL VENOUS BUNDLE 20CM
Published
2020-01-22
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
OESCardiac catheterization kit

Product Code Classifications

CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653160339239PackageGS15In Commercial Distribution
10653160339236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160339239006531603392396531603392390653160339239
1065316033923610653160339236

GMDN Terms

TermDefinition
Central venous catheterization kit, short-termA collection of sterile devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). 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
true
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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