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
00884450431252Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
00884450431979Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-04
10198956415195CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956426061CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956512528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956513617CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956517202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956543522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548190CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956548497CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956549340CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956553217CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956558618CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956559684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956561861CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956562202CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956562417CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956563704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956564848CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956566767CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956568457CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956569522CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570535CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570573CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956570610CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956571570CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956571884CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04
10198956572379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-04