FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
00811870030109
Brand
Custom Healthcare Systems Inc.
Company
Manus Medical, LLC
Model
B9-8598
Published
2018-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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 shuntAn implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to the peritoneal cavity, where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It typically consists of three main connected parts: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal catheter that channels the CSF to the peritoneal cavity. It is made of plastic and silicone materials; disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
800604196
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811870037979Manus Medical, LLCZZ-0683-12024-02-06
00811870033216Custom Healthcare Systems Inc.UNC-179142018-07-25
00811870035555Custom Healthcare Systems of VA, LLCCLT-199142021-06-18
00811870030703Custom Healthcare Systems Inc.VBS-18520C2018-10-19
00811870032943CUSTOM HEALTHCARE SYSTEMS, INCDT-0520192019-06-03
00811870034411Custom Healthcare Systems Inc.VBS-18520B2018-10-19
00811870035036Custom Healthcare Systems, Inc.DT-197142020-04-09
00811870035166Custom Healthcare Systems, Inc.CUS1365-022020-07-28
00811870035630Custom Healthcare Systems of VA, LLCDT-19714 v22021-07-12
00811870035661Custom Healthcare Systems of VA, LLCDT-193432021-07-15
00811870035883Custom Healthcare Systems Inc.VBS-191082019-03-07
00811870035890Custom Healthcare Systems Inc.11168030152019-03-07
00811870037863Manus Medical, LLCEMLP-20375-12023-12-20
00811870037986Manus Medical, LLCUNC-9800-02024-02-07
20811870037980Manus Medical, LLCUNC-9800-02024-02-07
20811870037973Manus Medical, LLCZZ-0683-12024-02-06
00811870037887Manus Medical, LLCLPGM-0012024-02-02
00811870037900Manus Medical, LLCLPGM-002-12024-02-02
00811870037917Manus Medical, LLCMMCUS11732024-02-02
00811870037924Manus Medical, LLCA2081V-72024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS196900Aligned Medical SolutionsAligned Medical SolutionsOGJ2026-09-25
10198956571822CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-09-22
10198956541917CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-09-21
10198956564176CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-09-21
10198956509498CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-08-26
10198956561878CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-08-26
B098AMS190500Aligned Medical SolutionsAligned Medical SolutionsOGJ2026-08-21
04046955966370Design Options®B. BRAUN MEDICAL INC.OGJ2026-08-17
00849233018099Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-08-14
10198956516755CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-31
10198956533219CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-31
10198956429512CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956470545CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956523760CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956530447CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956533493CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
00628725050287Nerve Block Tray Clint PharmaceuticalsCHS USA Inc.OGJ2026-07-20
00628725050294Nerve Block Tray Clint PharmaceuticalsCHS USA Inc.OGJ2026-07-20
10198956530010CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-20
00628725050188Nerve Block TrayCHS USA Inc.OGJ2026-07-17
00628725050195Nerve Block TrayCHS USA Inc.OGJ2026-07-17
00628725050201Nerve Block TrayCHS USA Inc.OGJ2026-07-17
10198956500785CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-09
10198956524620CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-09
04046955966394Design Options®B. BRAUN MEDICAL INC.OGJ2026-06-25
00849233017948Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-06-23
10198956481176CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-05
10198956458451CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-01
00849233014329Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-03-25
00628725050003Nerve Block TrayCHS USA Inc.OGJ2025-11-20