FDA.reportPublic FDA data

Custom Healthcare Systems of VA, LLC

Primary DI
20811870035559
Brand
Custom Healthcare Systems of VA, LLC
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
CLT-19914
Published
2021-06-18
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

Product Codes#

Code, Name table
CodeName
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870035559PackageGS110In Commercial Distribution
00811870035555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003555920811870035559
00811870035555008118700355558118700355550811870035555

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kit, non-medicatedA collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
175254820
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20811870035757Custom Healthcare Systems of VA, LLCCPT56102021-08-11
20811870035962Custom Healthcare Systems of VA, LLCCPT55002021-08-11
20811870035702Custom Healthcare Systems of VA, LLCA2081V-62021-08-09
20811870035740Custom Healthcare Systems of VA, LLCB9-16350D2021-08-09
20811870035689Custom Healthcare Systems of VA, LLCOSC-200612021-07-30
20811870035665Custom Healthcare Systems of VA, LLCDT-193432021-07-15
20811870035672Custom Healthcare Systems of VA, LLCB9-9754A2021-07-15
20811870035634Custom Healthcare Systems of VA, LLCDT-19714 v22021-07-12
20811870035580Custom Healthcare Systems of VA, LLCL4000-200272021-07-06
20811870035566Custom Healthcare Systems of VA, LLCKM-19796-12021-06-29
20811870035535Custom Healthcare Systems of VA, LLCB9-200082021-06-18
20811870035498Custom Healthcare Systems of VA, LLC36774662021-06-11
20811870035474Custom Healthcare Systems of VA, LLCL1000-199362021-06-10
20811870035528Custom Healthcare Systems of VA, LLCL1000-200002021-06-10
20811870035450Custom Healthcare Systems of VA, LLCMWM-18937-022021-06-04
20811870035443Custom Healthcare Systems of VA, LLCZZ-14112021-05-24
20811870035306Custom Healthcare Systems of VA, LLCZZ-14102021-05-07
20811870035382Custom Healthcare Systems of VA, LLCZZ-14132021-05-07
20811870035399Custom Healthcare Systems of VA, LLCZZ-14122021-05-07
20811870035429Custom Healthcare Systems of VA, LLCZZ-14092021-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450498996Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-30
10809160528150HalyardAVID MEDICAL, INC.OEZ2026-07-30
10809160528167HalyardAVID MEDICAL, INC.OEZ2026-07-30
00884450431672Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-29
00884450144046Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-28
10809160528020HalyardAVID MEDICAL, INC.OEZ2026-07-28
10198956423527CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956442191CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956459830CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956466388CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956466890CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956477131CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956478893CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956482449CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956493605CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956494770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956496187CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956499379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956504684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956505131CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956505674CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956514188CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956516298CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956516878CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956518742CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956520684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521513CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521643CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521667CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956524163CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27