FDA.reportPublic FDA data

2XChromosome

Primary DI
10850022610001
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
Rx
false
OTC
false
Sterile
false
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 wipe, non-sterileA non-sterile 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117588619
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008500226100042XChromosome(2X)200920WPWBOZY0082021-04-30
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
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
08859335502220POSE HEALTH CARE LIMITED POSE HEALTH CARE LIMITEDLRJ2025-09-05
00615375013458CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
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
00025469093455Ecolab Bleach Disinfectant WipeEcolab Inc.LRJ2025-05-09
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06976301910789YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910796YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
10197344017683MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28
10197344017690MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28