FDA.reportPublic FDA data

2XChromosome

Primary DI
00850022610004
Brand
2XChromosome
Company
Global Health Solutions LLC
Model
(2X)200920WP
Catalog number
WBOZY008
Device description
Personal Care Cleansing Wipes; individually wrapped, organic cotton, alcohol free
Published
2021-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LRJDisinfectant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850022610001PackageGS1120Not in Commercial Distribution
00850022610004PrimaryGS10
00850022610110Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002261000110850022610001
00850022610004008500226100048500226100040850022610004
00850022610110008500226101108500226101100850022610110

GMDN Terms#

Term, Definition table
TermDefinition
Skin cleaning wipeA device consisting of an absorbent fabric pre-soaked in a liquid solution [e.g., with a detergent, alcohol, saline, hyaluronic acid (HA), plant extracts] intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.

Regulatory Flags#

DUNS number
117588619
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008500226100112XChromosome(2X)200920PLLBOUN0012021-04-30
008500226100282XChromosome(2X)200920PBORN0022021-04-30
008500226100352XChromosome(2X)200920SPPBOSN0032021-04-30
008500226100422XChromosome330201TCCLN0042021-04-16
008500226100592XChromosome329201TCCRN0052021-04-16
008500226100662XChromosome328202TCCSN0062021-04-16
008500226100732XChromosome328201TCCPN0072021-04-16
108500226100012XChromosome(2X)200920WPWBOZY0082021-04-30
108500226100182XChromosome(2X)200920PLLBOUN0012021-04-30
108500226100252XChromosome(2X)200920PBORN0022021-04-30
108500226100322XChromosome(2X)200920SPPBOSN0032021-04-30
084329840023672XChromosome330201TCCLN0042021-04-16
108500226100562XChromosome329201TCCRN0052021-04-16
108500226100632XChromosome328202TCCSN0062021-04-16
108500226100702XChromosome328201TCCPN0072021-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04039239075479Citric Acid 50%B. BRAUN MEDICAL INC.LRJ2026-04-03
00884392008420Safety 1stDOREL JUVENILE GROUP, INC.LRJ2025-12-15
10197344169085MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
20197344169082MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
00850080488072flysoundShenzhen Flysounds Medical Technology Co.,Ltd.LRJ2025-11-14
H816PSC050Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantMicroCare, LLCLRJ2025-10-23
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00615375013472CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013455CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013479CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00815027010303DALTON WET WIPEDALTON MEDICAL CORPORATIONLRJ2025-05-15
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10197344017683MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28
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