FDA.reportPublic FDA data

MEDLINE

Primary DI
20653160349591
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
IOB7L
Catalog number
IOB7L
Device description
INTRO(8F+)/AVA3XI LONG OBTURATOR,STERILE
Published
2021-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653160349594PackageGS110In Commercial Distribution
20653160349591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1065316034959410653160349594
2065316034959120653160349591

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valve obturatorA sterile device designed to seal the sheath of a haemostasis valve to maintain sheath patency (i.e., to prevent blood from coagulating in the sheath and blocking access through the haemostasis valve). It is typically a long, thin, rod-like device made of plastic with a rounded distal tip and a cap at the proximal end; it is available in a variety of sizes (e.g., 4-13 French and 15-26 cm long). The proximal cap has a locking mechanism (e.g., a Luer-lock or snap lock) to hold it securely in place to prevent blood loss from the patient. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489069334NAMIC91400300914003002021-10-28
10193489069341NAMIC91400400914004002021-07-26
10193489077667NAMIC906324490190632449012022-02-23
10193489078039NAMICH74904490202H749044902022021-07-26
10193489111132MEDLINESTGWLR1865NTSTGWLR1865NT2021-07-18
10193489111149MEDLINESTGWLR3260NTSTGWLR3260NT2021-07-18
10193489111156MEDLINESTGWLR2135NTSTGWLR2135NT2021-07-18
10193489111163MEDLINESTGWLR2535JNTSTGWLR2535JNT2021-07-18
10193489111170MEDLINESTGWLR2535NTSTGWLR2535NT2021-07-18
10193489191653MEDLINEDYNDA2467DYNDA24672020-04-15
10193489196559MEDLINEMNS12330AMNS12330A2020-04-20
10653160343806MEDLINEMNS12330AMNS12330A2020-07-06
10653160346760MEDLINEECVC7165AECVC7165A2021-05-20
10653160366577MEDLINECVI5045CVI50452023-09-28
20193489087793Medline80045075800450752021-05-12
20653160349492MEDLINEGW1850IGW1850I2021-12-16
10193489006728MEDLINEURO12575URO125752026-10-23
10197344219261MEDLINEDYNDSCL1500RDYNDSCL1500R2026-10-23
10653160395461MEDLINEDYNDC3514BDYNDC3514B2026-10-24
10653160395713MEDLINEEBSI1586BEBSI1586B2026-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00389701011912GLIDESHEATH SLENDER TIBIAL PEDAL KITTERUMO MEDICAL CORPORATIONDYB2018-08-31
00389701011950GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011967GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011974GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011981GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701009261PINNACLETERUMO MEDICAL CORPORATIONDYB2018-03-21
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006178DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006185DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006192DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006208DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006215DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006222DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006239DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006246DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006253DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006260DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006277DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006796DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006802DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006970DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006987DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006994DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007007DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007168DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24