FDA.reportPublic FDA data

CUSTOM HEALTHCARE SYSTEMS, INC

Primary DI
20811870033586
Brand
CUSTOM HEALTHCARE SYSTEMS, INC
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
D6-10809
Published
2019-08-20
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
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870033586PackageGS150In Commercial Distribution
00811870033582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003358620811870033586
00811870033582008118700335828118700335820811870033582

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
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
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
58053326007021FLOQSwabs®COPAN ITALIA SPAKXG2026-03-20
10197344169214CARINGMEDLINE INDUSTRIES, INC.KXG2025-12-05
00840456216675JMUJMU DENTAL, INCKXG2025-11-12
00840456216682JMUJMU DENTAL, INCKXG2025-11-12
M220767003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
M220768003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
M220768013Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
00840456214916JMUJMU DENTAL, INCKXG2025-07-15
00840456214923JMUJMU DENTAL, INCKXG2025-07-15
58053326011653CLASSIQSwabCOPAN ITALIA SPAKXG2025-07-03
58053326011660CLASSIQSwabs™ FLOQ Swabs® COPAN ITALIA SPAKXG2025-07-03
00842558116402BactiSwab Dry PK/100REMEL, INC.KXG2025-06-19
00810180840958LabChoice Transport Swabs, Wooden Shaft, Cotton Tip, Sterile Dynarex CorporationKXG2025-02-28
00810180840965LabChoice Transport Swabs, Wooden Shaft, Viscose Tip, SterileDynarex CorporationKXG2025-02-28
00810180840972LabChoice Transport Swabs, Snappable Polystyrene Shaft, Cotton Tip, Sterile Dynarex CorporationKXG2025-02-28
00840117329706LabChoice Transport Swabs, Snappable Polystyrene Shaft, Viscose Tip, SterileDynarex CorporationKXG2025-02-28
00840165400372Starswab Dry SwabPretium Canada Packaging ULCKXG2025-02-21
00840165400396Starswab Dry SwabPretium Canada Packaging ULCKXG2025-02-21
05060166524524Oracol MALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
05060166525743Oracol SwabMALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
05060166524531Oracol+MALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
58053326011684FLOQSwabs® COPAN ITALIA SPAKXG2024-12-18
00603266511848Super BrushSuper Brush, LLCKXG2024-08-30
10603266530839Super BrushSuper Brush, LLCKXG2024-08-30
10603266531874Super BrushSuper Brush, LLCKXG2024-08-30
10603266533830Super BrushSuper Brush, LLCKXG2024-08-30
10603266534875Super BrushSuper Brush, LLCKXG2024-08-30
10603266541835Super BrushSuper Brush, LLCKXG2024-08-30
00842558116501BactiSwab (Dry) CS/500Remel Inc.KXG2024-08-14
58053326011509FLOQSwabs® COPAN ITALIA SPAKXG2024-07-02