FDA.reportPublic FDA data

MEDADV

Primary DI
10819667020255
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
OTC
false
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 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 table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080593067
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00819667020258MEDADVM209M2092018-04-10
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

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Primary DI, Brand, Company table
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10801902213515ARROWTELEFLEX INCORPORATEDMPB2023-04-27
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