FDA.report

MEDLINE

Primary DI
00653160347142
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
I305BF9A
Catalog number
I305BF9A
Device description
INTRODUCER,STD, INTRO-FLEX 9F
Published
2021-05-23
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
00653160347142PackageGS110In Commercial Distribution
10653160347149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160347142006531603471426531603471420653160347142
1065316034714910653160347149

GMDN Terms

TermDefinition
Central venous catheterization kit, short-termA collection of 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(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
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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