FDA.report

Ohio

Primary DI
00628101616151
Brand
Ohio
Company
OHIO MEDICAL, LLC
Model
FI-X-T15UO-DN-A
Catalog number
FI-X-T15UO-DN-A
Device description
IFM 0-15LPM TUBE US OXY DISS TYPE A
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
00628101616151PrimaryGS10

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06970966669167GENTEC®GENTEC(SHANGHAI)CORPORATIONCAX2024-11-16
10193489137644MEDLINEMEDLINE INDUSTRIES, INC.CAX2024-10-08
10193489141108MEDLINEMEDLINE INDUSTRIES, INC.CAX2024-10-08
10193489179545MEDLINEMEDLINE INDUSTRIES, INC.CAX2024-10-08
00848530098513Respiratory AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CAX2024-07-05
10848530101807Celon Wet Bands 30.5 x 25mmSUNSET HEALTHCARE SOLUTIONS, INC.CAX2024-03-20
10848530101814Celon Wet Bands 30.5 x 40mmSUNSET HEALTHCARE SOLUTIONS, INC.CAX2024-03-20
10848530101821Celon Wet Bands 66 x 120mmSUNSET HEALTHCARE SOLUTIONS, INC.CAX2024-03-20
10193489017328MedlineMEDLINE INDUSTRIES, INC.CAX2024-03-05
00810003754660KENTEXKENTRON HEALTHCARE, INC.CAX2024-02-19
00810003754677KENTEXKENTRON HEALTHCARE, INC.CAX2024-02-19
00026072017999PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018002PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018019PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018026PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018033PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018040PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018057PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018064PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018071PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018088PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018095PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018101PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018118PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018125PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018132PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018149PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018156PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018163PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018170PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22