FDA.reportPublic FDA data

Ohio

Primary DI
00628101609962
Brand
Ohio
Company
OHIO MEDICAL, LLC
Model
ST01
Catalog number
6700-0234-700
Device description
Overflow Safety Trap
Published
2021-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDPREGULATOR, VACUUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628101609962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628101609962006281016099626281016099620628101609962

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, reusableA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(847)855-6218customer.service@ohiomedical.com

Regulatory Flags#

DUNS number
005192885
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628101633356OhioHS-01UC-DADCN4HS-01UC-DADCN42026-09-29
00628101633417OhioHS-13IO-DCDEC4HS-13IO-DCDEC42026-09-29
00628101620387OhioGR-CS-PA-01001GR-CS-PA-010012026-05-18
00628101620837OhioGR-CS-AS-01001GR-CS-AS-010012026-05-18
00628101620851OhioGR-MU-00101GR-MU-001012026-05-18
00628101632618OhioAM-TH300440AM-TH3004402026-05-18
00628101632625OhioGR-F4OGR-F4O2026-05-18
00628101632496Ohio HS-13IV-DFXXC4 HS-13IV-DFXXC42026-05-13
00628101632502OhioHS-13U2-DFXXC4HS-13U2-DFXXC42026-05-13
00628101632557Ohio HS-01UW-CFCMC4 HS-01UW-CFCMC42026-05-13
00628101632472OhioHS-15UV-F2CMC4HS-15UV-F2CMC42026-05-06
00628101632519OhioHS-20UO-DEOEC4HS-20UO-DEOEC42026-05-06
00628101632526Ohio HS-20UA-DAOEC4 HS-20UA-DAOEC42026-05-06
00628101632540OhioHS-25UI-DFXXC4HS-25UI-DFXXC42026-05-06
00628101632434Ohio HS-30U2-CFDFC4 HS-30U2-CFDFC42026-05-05
00628101632441Ohio HS-30UW-CFDFC5 HS-30UW-CFDFC52026-05-05
00628101632533OhioHS-CS-RM-02002HS-CS-RM-020022026-05-05
00628101632489Ohio HS-25UC-DFF4C4 HS-25UC-DFF4C42026-04-17
00628101608187OhioFI-T01UO-DN-EFI-T01UO-DN-E2026-04-15
00628101608194OhioFI-T01UO-ON-EFI-T01UO-ON-E2026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344148592MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-09-30
10197344148332MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-09-04
10197344148707MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-09-04
08435510650872TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510655150TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679033TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679064TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679071TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679088TITANIUM VAC REGHERSILL SLKDP2026-08-25
10197344144181MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-08-07
10197344144693MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144709MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144716MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144723MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144730MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144747MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144754MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144761MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144778MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144785MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144792MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144808MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144815MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144822MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146161MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146178MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146185MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146192MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146208MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146215MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24