FDA.reportPublic FDA data

Solventum™ Ioban™

Primary DI
00197998149689
Brand
Solventum™ Ioban™
Company
Solventum US LLC
Model
8840EZSB
Catalog number
8840EZSB
Device description
Solventum™ Ioban™ CHG Chlorhexidine gluconate incise drape (contains 2% w/w CHG), 8840EZSB, 34 cm x 35 cm (13 in x 13 in), 100/CS
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKXdrape, surgical, antimicrobial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998149696PackageGS1100In Commercial Distribution
00197998149689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998149696001979981496961979981496960197998149696
00197998149689001979981496891979981496890197998149689

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-2249regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119004140
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998346842Solventum™ Steri-Strip™R1546NSR1546NS2026-11-02
00197998346927Solventum™ Steri-Strip™R1548R15482026-11-02
00197998347009Solventum™ Steri-Strip™R1541SBR1541SB2026-11-02
00197998347283Solventum™ Steri-Strip™R1542SBR1542SB2026-11-02
00197998001239Solventum™ Tegaderm™1877-21001877-21002026-08-23
00197998001260Solventum™ Tegaderm™1879-21001879-21002026-08-23
00197998001352Solventum™ Tegaderm™166416642026-08-23
00197998149559Solventum™ Ioban™8840EZ8840EZ2026-10-30
00197998149580Solventum™ Ioban™8851EZ8851EZ2026-10-30
00197998149610Solventum™ Ioban™8850EZSB8850EZSB2026-10-30
00197998149634Solventum™ Ioban™8850EZ8850EZ2026-10-30
00197998149665Solventum™ Ioban™8851EZSB8851EZSB2026-10-30
00197998346750Solventum™ Steri-Strip™A1847A18472026-10-31
00197998346781Solventum™ Steri-Strip™T1545NST1545NS2026-10-31
00197998346804Solventum™ Steri-Strip™R1548NSR1548NS2026-10-31
00197998346828Solventum™ Steri-Strip™R1547NSR1547NS2026-10-31
00197998346866Solventum™ Steri-Strip™R1541NSR1541NS2026-10-31
00197998346880Solventum™ Steri-Strip™R1546R15462026-10-31
00197998346965Solventum™ Steri-Strip™R1549R15492026-10-31
00197998347030Solventum™ Steri-Strip™R1540SBR1540SB2026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998149559Solventum™ Ioban™Solventum US LLCKKX2026-10-30
00197998149580Solventum™ Ioban™Solventum US LLCKKX2026-10-30
00197998149610Solventum™ Ioban™Solventum US LLCKKX2026-10-30
00197998149634Solventum™ Ioban™Solventum US LLCKKX2026-10-30
00197998149665Solventum™ Ioban™Solventum US LLCKKX2026-10-30
06975424191068Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-09-30
10809160539125HalyardMEDICAL ACTION INDUSTRIES INC.KKX2026-09-30
06975424191044Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-09-29
06975424191006Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-09-21
10801902196665ARROWTELEFLEX INCORPORATEDKKX2026-07-28
06975424190771Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-07-16
00628110259448MolecuLightDX Sterile Surgical Sleeve Convenience Kit of 25MolecuLight IncKKX2026-07-08
10801902225808ARROWTELEFLEX INCORPORATEDKKX2026-05-06
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10