FDA.reportPublic FDA data

FLOWMETER, DIAL

Primary DI
00628101502799
Brand
FLOWMETER, DIAL
Company
OHIO MEDICAL, LLC
Model
FM-D-25IA
Device description
FM-D series, 25 LPM, ISO, 50PSI, AIR
Published
2020-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCNFlowmeter, Nonback-Pressure Compensated, Bourdon GaugeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628101502799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628101502799006281015027996281015027990628101502799

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas flowmeter, dial-typeA device intended to 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 has a pre-calibrated adjustable flow selection dial intended to control the gas flow rate; it is not intended to provide flow rate measurements. 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
1 847 855 0500CUSTOMER.SERVICE@OHIOMEDICAL.COM

Regulatory Flags#

DUNS number
005192885
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628101624248OhioFM-LT-1515NOFM-LT-1515NO2026-10-22
00628101624385OhioFM-LT-0303NOFM-LT-0303NO2026-10-22
00628101624392OhioFM-T-0101NOFM-T-0101NO2026-10-22
00628101624408OhioFM-T-0303NOFM-T-0303NO2026-10-22
00628101624415OhioFM-T-1515NOFM-T-1515NO2026-10-22
00628101629236OhioFM-LT-1515UOFM-LT-1515UO2026-10-22
00628101629243OhioFM-OT-1515UOFM-OT-1515UO2026-10-22
00628101629250OhioFM-T-1515UOFM-T-1515UO2026-10-22
00628101629922OhioFM-T-1515NAFM-T-1515NA2026-10-22
00628101629939OhioFM-OT-1515NOFM-OT-1515NO2026-10-22
00628101630379OhioFM-OT-1515NAFM-OT-1515NA2026-10-22
00628101630386OhioFM-T-1515IOFM-T-1515IO2026-10-22
00628101630454OhioFM-T-1515UAFM-T-1515UA2026-10-22
00628101630461OhioFM-OT-0315UOFM-OT-0315UO2026-10-22
00628101630683OhioFM-LT-1515SOFM-LT-1515SO2026-10-22
00628101631093OhioFM-T-0101IOFM-T-0101IO2026-10-22
00628101631109OhioFM-T-0101UOFM-T-0101UO2026-10-22
00628101631116OhioFM-T-0303IOFM-T-0303IO2026-10-22
00628101631123OhioFM-T-0303UOFM-T-0303UO2026-10-22
00628101631130OhioFM-T-0808IOFM-T-0808IO2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00026072022429EMAllied Medical, LLCCCN2024-10-11
00026072022436EMAllied Medical, LLCCCN2024-10-11
06977645350170SINYADanyang Xinya Valve Co., Ltd.CCN2024-08-06
16977645350177SINYADanyang Xinya Valve Co., Ltd.CCN2024-08-06
00026072022399EMAllied Medical, LLCCCN2024-05-28
00026072022405EMAllied Medical, LLCCCN2024-05-28
00026072022412EMAllied Medical, LLCCCN2024-05-28
07540200000460Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000477Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000484Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000491Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000545Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000552Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540195050051O-Two O-Two Medical Technologies IncCCN2023-11-07
07540195050075O-Two O-Two Medical Technologies IncCCN2023-11-07
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00628101502782FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
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00628101502720FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
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00628101502744FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502751FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04