FDA.report

INTROCAN SAFETY®

Primary DI
04046963318000
Brand
INTROCAN SAFETY®
Company
B. BRAUN MEDICAL INC.
Model
4253590-02
Catalog number
4253590-02
Device description
Introcan Safety® IV Catheter 18 Ga. x 1.75 in., PUR, Winged
Published
2016-09-23
Public version status
Update
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
DYBINTRODUCER, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046963318000PackageGS14In Commercial Distribution
04046963318277PrimaryGS10
04046963317669Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046963318000040469633180004046963318000
04046963318277040469633182774046963318277
04046963317669040469633176694046963317669

GMDN Terms

TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor microcatheter for access into superselective small vessels. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbra
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags

DUNS number
002397347
Device count
50
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
true
Sterilization required before use
false

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04046955745753Introcan Safety ® 24242001-024242001-022025-12-19
04046955745838Introcan Safety ® 24242003-024242003-022025-12-19
04046955745913Introcan Safety ® 24242005-024242005-022025-12-19
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