FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
20811870032701
Brand
Custom Healthcare Systems Inc.
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
YMUVC-200
Published
2018-10-03
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
OESCardiac Catheterization Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870032701PackageGS112In Commercial Distribution
00811870032707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003270120811870032701
00811870032707008118700327078118700327070811870032707

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
175254820
Device count
1
DM exempt
false
Premarket exempt
true
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
20811870035559Custom Healthcare Systems of VA, LLCCLT-199142021-06-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160521847HalyardAVID MEDICAL, INC.OES2026-05-26
10198956478855CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956485457CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956486775CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956488618CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
20809160517236HalyardAVID MEDICAL, INC.OES2026-03-24
50198956364194CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956380385CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956415070CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956433234CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
20809160517120HalyardAVID MEDICAL, INC.OES2026-03-23
20809160516871HalyardAVID MEDICAL, INC.OES2026-03-20
20809160516895HalyardAVID MEDICAL, INC.OES2026-03-20
20809160516956HalyardAVID MEDICAL, INC.OES2026-03-20
50198956404272CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
50198956410518CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
50198956412826CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
40198459589899MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459594985MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611538MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611552MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611569MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459611576MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459613556MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616618MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616625MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616632MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616649MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459619466MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459619770MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16