FDA.reportPublic FDA data

Amico Patient Care Corporation

Primary DI
07540200000491
Brand
Amico Patient Care Corporation
Company
Amico Patient Care Corporation
Model
FMO-08-D
Device description
Dial Flowmeter, Oxygen, 8 LPM
Published
2023-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07540200000491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540200000491075402000004917540200000491

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

Regulatory Flags#

DUNS number
259676661
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540200000385Amico Patient Care CorporationFMA-152023-11-14
07540200000392Amico Patient Care CorporationFMO-152023-11-14
07540200000408Amico Patient Care CorporationFMO-012023-11-14
07540200000415Amico Patient Care CorporationFMO-022023-11-14
07540200000422Amico Patient Care CorporationFMO-032023-11-14
07540200000439Amico Patient Care CorporationFMO-082023-11-14
07540200000446Amico Patient Care CorporationFMA-702023-11-14
07540200000453Amico Patient Care CorporationFMO-702023-11-14
07540200000460Amico Patient Care CorporationFMA-25-D2023-11-14
07540200000477Amico Patient Care CorporationFMO-25-D2023-11-14
07540200000484Amico Patient Care CorporationFMO-04-D2023-11-14
07540200000545Amico Patient Care CorporationFMO-15-D2023-11-14
07540200000552Amico Patient Care CorporationFMA-15-D2023-11-14
07540200000330Amico Patient Care CorporationAVA SERIES2016-09-24
07540200000347Amico Patient Care CorporationMARCO SERIES2016-09-24
07540200000354Amico Patient Care CorporationCONNOR SERIES2016-09-24
07540200000361Amico Patient Care CorporationJORDAN SERIES2017-09-12
07540200000378Amico Patient Care CorporationLILY SERIES2017-09-12
07540200000019Amico Patient Care CorporationSRA-C22016-09-24
07540200000026Amico Patient Care CorporationSRD-C22016-09-24

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
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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