FDA.reportPublic FDA data

GENTEC®

Primary DI
06970966663929
Brand
GENTEC®
Company
GENTEC(SHANGHAI)CORPORATION
Model
FM197A -70L-HS Series
Device description
FM197A Series 70L flowmeter with hose and accessories, oxygen.
Published
2023-06-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories
CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970966663929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970966663929069709666639296970966663929

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
545287658
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970966665220GENTEC®34U-OXY2023-08-01
06970966665886GENTEC®O-W200-F70-GS2023-08-01
06970966665893GENTEC®O-W200-F70-BS2023-08-01
06970966665909GENTEC®O-G200-F70-DS2023-08-01
06970966665916GENTEC®O-W200-F70-DS2023-08-01
06970966663936GENTEC®O-W200-F70 Series2023-07-05
06970966663721GENTEC®34I-OXY Series2023-06-21
06970966663776GENTEC®35I-OXY Series2023-06-21
06970966663820GENTEC®34U-OXY Series2023-06-21
06970966663875GENTEC®35U-OXY Series2023-06-21
06970966669167GENTEC®FMD197A Series2024-11-16
06970966669068GENTEC®FM-PTO2024-08-05
06970966669037GENTEC®Y-VAC-CPLR-OH2024-07-26
06970966669044GENTEC®Y-VAC-CPLR-DH2024-07-26
06970966669051GENTEC®Y-OXY-CPLR-OH2024-07-26
06970966666753GENTEC®195M-950D2024-06-28
06970966666371GENTEC® GMX30E-AIR/O2-DS-P152024-03-25
06970966666357GENTEC®882VR-200-00-T2023-12-26
06970966666340GENTEC®882VR-200-DS-T-1.5L2023-12-20
06970966666111GENTEC®881VR-200-DS-T-2.5L/Sld2023-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919220Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919237Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919244Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919251Salter Labs® Oxygen Tubing (MedTronic)SALTER LABSBYX2026-06-09
B929C4NI024FNNFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4AIK240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4OXW240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
00848530108328Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-03
00848530108953Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108960Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108977Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109011Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109028Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109035Repair PartSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109073Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
06978651650766KYCAREFoshan KYCARE Medical Equipment Co., Ltd.CAX2026-05-30
09420012408860Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAX2026-03-26
09420012408884Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAX2026-03-26
10197344011230HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-13
10197344011155HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10197344042401HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10885632467431HalyardOWENS & MINOR DISTRIBUTION, INC.BYX2026-01-29
10889483225639AirLife™SUNMED, LLCBYX2025-12-18
10889483229279AirLife™SUNMED, LLCBYX2025-12-18
10197344162710MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344162727MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344011780HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012237HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012244HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012572HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03