FDA.reportPublic FDA data

Sure-Trap

Primary DI
00628101609528
Brand
Sure-Trap
Company
OHIO MEDICAL, LLC
Model
70365
Device description
Overflow Safety Trap
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00628101609528PackageGS112In Commercial Distribution
00628101609535PackageGS125In Commercial Distribution
00628101609542PackageGS150In Commercial Distribution
08688250002597PreviousGS10
00628101609511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628101609528006281016095286281016095280628101609528
00628101609535006281016095356281016095350628101609535
00628101609542006281016095426281016095420628101609542
08688250002597086882500025978688250002597
00628101609511006281016095116281016095110628101609511

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum suction regulator/regulation set, general-purposeA noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18478550500customer.service@ohiomedical.com

Regulatory Flags#

DUNS number
005192885
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00628101548254OhioHS-10IA-DFDMC4HS-10IA-DFDMC42026-03-24
00628101559618OhioHS-12IA-DHOMC4HS-12IA-DHOMC42026-03-24
00628101595708OhioHS-36U2-DHDCC4HS-36U2-DHDCC42026-03-24
00628101599980OhioHS-CS-GE-02026HS-CS-GE-020262026-03-24
00628101622374OhioHS-14UN-SFSSC4HS-14UN-SFSSC42026-03-24
00628101631543OhioHS-04UI-DHDMC4HS-04UI-DHDMC42026-03-24
00628101631567OhioHS-12UW-F4CMN5HS-12UW-F4CMN52026-03-24
00628101631574OhioHS-22IA-DFDFC4HS-22IA-DFDFC42026-03-24
00628101631628OhioHS-40UN-DFM4N4HS-40UN-DFM4N42026-03-24
00628101631635OhioHS-21IA-DBDFC4HS-21IA-DBDFC42026-03-24
00628101631642OhioHS-03IA-DHOFC4HS-03IA-DHOFC42026-03-24
00628101631673OhioHS-20UV-CADHN4HS-20UV-CADHN42026-03-24
00628101631680OhioHS-06IV-DHDHN4HS-06IV-DHDHN42026-03-24
00628101631703OhioHS-25SA-DHDHC4HS-25SA-DHDHC42026-03-24
00628101631710OhioHS-30SA-DHDHC4HS-30SA-DHDHC42026-03-24
00628101631727OhioHS-08UO-CFF4N4HS-08UO-CFF4N42026-03-24
00628101631734OhioHS-08UW-F4CMN5HS-08UW-F4CMN52026-03-24
00628101631741OhioHS-20UO-F4CMN4HS-20UO-F4CMN42026-03-24
00628101631758OhioHS-20UW-CFF4N5HS-20UW-CFF4N52026-03-24
00628101631802OhioHS-45UW-OFOMC4HS-45UW-OFOMC42026-03-24

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08435510679873TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680039TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680046TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680053TITANIUM VAC REGHERSILL SLKDP2026-01-07
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