FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160349426
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CC0280
Catalog number
CC0280
Device description
CONTAM SHLD FOR INTROFLEX AUTOVALVE 80CM
Published
2021-12-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGZACCESSORIES, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653160349426PackageGS140In Commercial Distribution
20653160349423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1065316034942610653160349426
2065316034942320653160349423

GMDN Terms#

Term, Definition table
TermDefinition
Peripherally-inserted central venous catheterA thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20653160392375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KGZ2026-02-26
06937440443811YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
06937440443828YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
40198459435202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
40704411017883AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
04048223118702FixoLongPajunk GmbH MedizintechnologieKGZ2025-04-04
05708932767811SopranoColoplast A/SKGZ2025-03-26
20192253053606DevonCardinal Health 200, LLCKGZ2025-03-25
20192253042020DevonCardinal Health 200, LLCKGZ2025-03-07
20192253042037DevonCardinal Health 200, LLCKGZ2025-03-07
00840306834936Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
00840306835155Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
00840306835124Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-10
00860012804405BladeClearPATHWAY MEDTECH, LLCKGZ2024-11-04
00860012804412BladeClearPATHWAY MEDTECH, LLCKGZ2024-11-04
00840306836039Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-23
10884521811546RitusCovidien LPKGZ2024-10-21
00840306835162Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835179Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835186Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835209Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835216Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835223Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835230Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835247Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
05708932767545Insertion ToolCOLOPLAST CORP.KGZ2024-09-27
50382904275650BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
50382904275612BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275629BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275636BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20