FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
20811870030103
Brand
Custom Healthcare Systems Inc.
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
B9-8598
Published
2018-07-29
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
OGJNerve Block Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGJNerve Block TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870030103PackageGS150In Commercial Distribution
00811870030109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003010320811870030103
00811870030109008118700301098118700301090811870030109

GMDN Terms#

Term, Definition table
TermDefinition
Ventriculoperitoneal shuntA sterile implantable device intended to divert excessive cerebrospinal fluid (CSF) from the ventricles (fluid-filled cavities) of the brain to the peritoneal cavity, where it can be absorbed into the body. It typically consists of three main parts: 1) a ventricular catheter with holes which allow the CSF to drain through the catheter and to; 2) a mechanical ventriculoperitoneal (VP) shunt valve that typically opens at a pre-set pressure; and 3) a distal catheter that channels the CSF to the peritoneal cavity. This device is intended as a therapeutic measure for situations where increased CSF causes increased intracranial pressure (hydrocephalus).

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
10198956300316CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-05-25
10198956364813CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-05-25
10198956464032CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-05-25
50198956330571CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-23
50198956352627CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-23
50198956408638CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-23
50198956390971CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-19
50198956337655CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-16
50198956348927CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-16
50198956406269CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-16
50198956325027CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-10
50198956350579CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-10
50198956386592CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-10
50198956402568CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-10
50198956387100CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-09
50198956383843CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-03
04046955897186Design Options®B. BRAUN MEDICAL INC.OGJ2026-03-02
50198956270198CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-02
50198956368635CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-02
50198956383904CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-02
50198956391848CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-03-02
50198956310689CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-02-23
50198956339871CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-02-23
50198956368581CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-02-23
50198956374803CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-02-20
50198956271157CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-02-09
50198956360394CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-02-09
10849233014319Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-02-02
00191072241726ACSAMERICAN CONTRACT SYSTEMS, INC.OGJ2026-02-02
50198956337259CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-02-02