FDA.reportPublic FDA data

Solventum Coban

Primary DI
00197998414701
Brand
Solventum Coban
Company
Solventum US LLC
Model
20016
Catalog number
20016
Device description
20016 COBAN 2 LYR COMP SYS 40/CS DH
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998414718PackageGS110In Commercial Distribution
00197998414701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998414718001979984147181979984147180197998414718
00197998414701001979984147011979984147010197998414701

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-2263regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119004140
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998383243Solventum Coban2794E2794E2026-11-05
00197998383366Solventum Coban20724207242026-11-05
00197998383403Solventum Coban20726207262026-11-05
00197998383489Solventum Coban20714207142026-11-05
00197998383526Solventum Coban20716207162026-11-05
00197998383564Solventum Coban20012200122026-11-05
00197998383601Solventum Coban209420942026-11-05
00197998383632Solventum Coban209220922026-11-05
00197998401626Solventum Coban20096200962026-11-05
00197998401664Solventum Coban2094N2094N2026-11-05
00197998414541Solventum Coban20721207212026-11-05
00197998414589Solventum Coban20022200222026-11-05
00197998414626Solventum Coban20024200242026-11-05
00197998414664Solventum Coban20026200262026-11-05
00197998437717Solventum Coban20014200142026-11-05
00197998437755Solventum Coban2094XL2094XL2026-11-05
00197998346842Solventum™ Steri-Strip™R1546NSR1546NS2026-11-02
00197998346927Solventum™ Steri-Strip™R1548R15482026-11-02
00197998347009Solventum™ Steri-Strip™R1541SBR1541SB2026-11-02
00197998347283Solventum™ Steri-Strip™R1542SBR1542SB2026-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998383243Solventum CobanSolventum US LLCFQM2026-11-05
00197998383366Solventum CobanSolventum US LLCFQM2026-11-05
00197998383403Solventum CobanSolventum US LLCFQM2026-11-05
00197998383489Solventum CobanSolventum US LLCFQM2026-11-05
00197998383526Solventum CobanSolventum US LLCFQM2026-11-05
00197998383564Solventum CobanSolventum US LLCFQM2026-11-05
00197998383601Solventum CobanSolventum US LLCFQM2026-11-05
00197998383632Solventum CobanSolventum US LLCFQM2026-11-05
00197998401626Solventum CobanSolventum US LLCFQM2026-11-05
00197998401664Solventum CobanSolventum US LLCFQM2026-11-05
00197998414541Solventum CobanSolventum US LLCFQM2026-11-05
00197998414589Solventum CobanSolventum US LLCFQM2026-11-05
00197998414626Solventum CobanSolventum US LLCFQM2026-11-05
00197998414664Solventum CobanSolventum US LLCFQM2026-11-05
00197998437717Solventum CobanSolventum US LLCFQM2026-11-05
00197998437755Solventum CobanSolventum US LLCFQM2026-11-05
06975675785054RESCUE RESSENTIALSEMSRUN GROUPFQM2026-10-27
20885380214377KendallCardinal Health 200, LLCFQM2026-10-12
20885380214384KendallCardinal Health 200, LLCFQM2026-10-12
20885380214391KendallCardinal Health 200, LLCFQM2026-10-12
20885380214407KendallCardinal Health 200, LLCFQM2026-10-12
20885380214414KendallCardinal Health 200, LLCFQM2026-10-12
07333350030384Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350102111Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350354831Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350472917Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350589110Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350644635Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350721589Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350753856Tubigrip®Mölnlycke Health Care ABFQM2026-09-21