FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
20811870032091
Brand
Custom Healthcare Systems Inc.
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
BTPS 004XL
Published
2019-01-23
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

Product Codes#

Code, Name table
CodeName
OFACardiovascular Surgical Instruments Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFACardiovascular Surgical Instruments TrayCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870032091PackageGS11In Commercial Distribution
00811870032097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003209120811870032091
00811870032097008118700320978118700320970811870032097

GMDN Terms#

Term, Definition table
TermDefinition
Surgical preparation kitA collection of sterile devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. 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
10197106720967CARDINAL HEALTHCardinal Health 200, LLCOFA2024-11-15
50197106720965CARDINAL HEALTHCardinal Health 200, LLCOFA2024-11-15
10197106636435CARDINAL HEALTHCardinal Health 200, LLCOFA2024-05-16
50197106636433CARDINAL HEALTHCardinal Health 200, LLCOFA2024-05-16
10197106457368CARDINAL HEALTHCardinal Health 200, LLCOFA2023-12-06
10809160413616Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2023-12-06
50197106457366CARDINAL HEALTHCardinal Health 200, LLCOFA2023-12-06
20809160413613Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2023-12-06
10197106458495CARDINAL HEALTHCardinal Health 200, LLCOFA2023-10-13
50197106458493CARDINAL HEALTHCardinal Health 200, LLCOFA2023-10-13
00851788001174On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001730On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001747On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001006On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-08
10197106140499CARDINAL HEALTHCardinal Health 200, LLCOFA2023-02-16
50197106140497CARDINAL HEALTHCardinal Health 200, LLCOFA2023-02-16
10195594468828CARDINAL HEALTHCardinal Health 200, LLCOFA2022-02-15
50195594468826CARDINAL HEALTHCardinal Health 200, LLCOFA2022-02-15
10809160360156Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2021-09-27
20809160360153Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2021-09-27
00749756714402DeRoyalDEROYAL INDUSTRIES, INC.OFA2021-06-23
50749756714407DeRoyalDEROYAL INDUSTRIES, INC.OFA2021-06-23
10195594135928CARDINAL HEALTHCardinal Health 200, LLCOFA2021-06-10
50195594135926CARDINAL HEALTHCardinal Health 200, LLCOFA2021-06-10
10809160284223Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2020-05-28
20809160284220Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2020-05-28
00811870033568CUSTOM HEALTHCARE SYSTEMS, INC.Manus Medical, LLCOFA2019-07-29
20811870033562CUSTOM HEALTHCARE SYSTEMS, INC.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-07-29
00811870032264Custom Healthcare Systems, Inc.Manus Medical, LLCOFA2019-06-24
00811870032677Custom Healthcare Systems, Inc.Manus Medical, LLCOFA2019-06-24