FDA.reportPublic FDA data

MEDADV

Primary DI
00819667020258
Brand
MEDADV
Company
MEDAS INC
Model
M209
Catalog number
M209
Device description
CENTRAL VENOUS CATETHER TRIPLE LUMEN 7 Fr X 15 CM
Published
2018-04-10
Public version status
Update
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
MPBCatheter, Hemodialysis, Non-Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPBCatheter, Hemodialysis, Non-ImplantedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102833000DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETSFoshan Nanhai Bai HE Medical Technology Co., Ltd.2011-11-18MPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819667020255PackageGS110In Commercial Distribution
00819667020258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081966702025510819667020255
00819667020258008196670202588196670202580819667020258

GMDN Terms#

Term, Definition table
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.

Contacts#

Phone, Email table
PhoneEmail
+1(786)832-0459customerservice@medasusa.com

Regulatory Flags#

DUNS number
080593067
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819667020746MEDADVM95F61135JM95F61135J2018-04-09
00819667020753MEDADVM95R50721SM95R0721S2018-04-09
00819667020784MEDADVM962P0SM962P0S2018-04-11
00819667020791MEDADVM962P20XLM962P20XL2018-04-11
00819667020807MEDADVM962P20M962P202018-04-11
00819667020814MEDADVM962P20LM962P20L2018-04-11
00819667020647MEDADVM93135150AM93135150A2018-04-11
00819667020654MEDADVM93135260AM93135260A2018-04-09
00819667020166MEDADVM101M1012018-04-12
00819667020982MEDADVM507M5072018-04-11
00819667020265MEDADVM206M2062018-04-11
00819667020272MEDADVM207M2072018-04-10
00819667020289MEDADVM210M2102018-04-09
10819667020064MEDADVM711M7112018-03-01
10819667020071MEDADVM712M7122018-03-01
10819667020088MEDADVM713M7132018-03-01
10819667020095MEDADVM714M7142018-03-01
10819667020101MEDADVM716M7162018-03-01
10819667020118MEDADVM717M7172018-03-01
00819667020043MEDADVM705M7052018-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902222265ARROWTELEFLEX INCORPORATEDMPB2025-06-12
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10801902222296ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222302ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222319ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222241ARROWTELEFLEX INCORPORATEDMPB2025-06-10
10801902221923ARROWTELEFLEX INCORPORATEDMPB2025-05-13
10801902222487ARROWTELEFLEX INCORPORATEDMPB2025-04-04
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10801902202410ARROWTELEFLEX INCORPORATEDMPB2024-09-06
10801902202427ARROWTELEFLEX INCORPORATEDMPB2024-09-06
10853072007173Dual Lumen Extended Length Catheter (15cm)Nuwellis Inc.MPB2024-02-20
10853072007210Dual Lumen Extended Length Catheter (11cm) and GALT Insertion KitNuwellis Inc.MPB2024-02-20
10853072007234Dual Lumen Extended Length Catheter (15cm) and GALT Insertion KitNuwellis Inc.MPB2024-02-20
10801902213638ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213652ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213676ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213683ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213690ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213706ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213713ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213478ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213492ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213515ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213539ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213546ARROWTELEFLEX INCORPORATEDMPB2023-04-27