FDA.report

Sure-Trap

Primary DI
08688250002597
Brand
Sure-Trap
Company
OHIO MEDICAL, LLC
Model
70365
Catalog number
7725-0365-901
Device description
Overflow Safety Trap
Published
2017-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KDPRegulator, Vacuum

Product Code Classifications

CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08688250002603PackageGS112Not in Commercial Distribution
08688250002610PackageGS125Not in Commercial Distribution
08688250002627PackageGS150Not in Commercial Distribution
08688250002597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08688250002603086882500026038688250002603
08688250002610086882500026108688250002610
08688250002627086882500026278688250002627
08688250002597086882500025978688250002597

GMDN Terms

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

Contacts

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
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 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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