FDA.report

Ohio

Primary DI
00628101616083
Brand
Ohio
Company
OHIO MEDICAL, LLC
Model
FI-X-T15UO-DN-E-PM
Catalog number
FI-X-T15UO-DN-E-PM
Device description
IFM 0-15LPM TUBE US OXY DISS TYPE E-PM
Published
2022-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CAXFlowmeter, tube, thorpe, back-pressure compensated

Product Code Classifications

CodeDeviceSpecialtyClass
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00628101616083PrimaryGS10

GMDN Terms

TermDefinition
Medical gas flowmeter, Thorpe tubeA device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(847)855-6218customer.service@ohiomedical.com

Regulatory Flags

DUNS number
005192885
Device count
1
DM exempt
true
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 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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