FDA.reportPublic FDA data

MEDLINE

Primary DI
00653160360431
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CVI4915A
Catalog number
CVI4915A
Device description
ECMO INSERTION BUNDLE W/O CANNULA
Published
2023-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRSI.V. start kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160360431PackageGS13In Commercial Distribution
10653160360438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160360431006531603604316531603604310653160360431
1065316036043810653160360438

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
true
Combination product
true
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
10653160393306MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-26
50198956425345CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-23
50198956373141CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-19
50198956374711CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-19
50810010894927Aero-MedAERO-MED, LLCLRS2026-03-17
50810010894934Aero-MedAERO-MED, LLCLRS2026-03-17
00810010894977Aero-MedAERO-MED, LLCLRS2026-03-17
00810010894984Aero-MedAERO-MED, LLCLRS2026-03-17
50198956398571CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-16
50198956406597CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-16
50198956375428CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-10
10653160392576Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-05
10653160392637Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-05
10653160392682Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-05
20809160514938Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRS2026-03-04
50198956348828CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-03
20809160514754MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.LRS2026-03-03
20809160514761MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.LRS2026-03-03
50198956332063CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-02
50198956348446CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-02
10653160392583Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-02
10653160392323Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-26
10653160392385Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-26
10653160392460Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-26
50198956323528CARDINAL HEALTHCardinal Health 200, LLCLRS2026-02-23
50198956363616CARDINAL HEALTHCardinal Health 200, LLCLRS2026-02-23
10653160392057Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-11
10653160392064Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-11
10653160392231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-11
00842209137619NAR KitNORTH AMERICAN RESCUE, LLCLRS2026-02-10