FDA.reportPublic FDA data

Custom Healthcare Systems of VA, LLC

Primary DI
20811870035634
Brand
Custom Healthcare Systems of VA, LLC
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
DT-19714 v2
Published
2021-07-12
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
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870035634PackageGS110In Commercial Distribution
00811870035630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003563420811870035634
00811870035630008118700356308118700356300811870035630

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar puncture kitA collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. 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
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
20811870035429Custom Healthcare Systems of VA, LLCZZ-14092021-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160522332HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522349HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522356HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522363HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522370HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522394HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522400HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522448HalyardAVID MEDICAL, INC.LRO2026-06-02
10198956004887CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956245754CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956248908CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956312043CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956314634CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956314894CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956321717CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956356184CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956370760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956376793CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956377363CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956384750CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956384873CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956385078CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956385160CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956391970CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956406193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956439399CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956440685CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956444065CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956444850CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956445833CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01