FDA.reportPublic FDA data

GENTEC®

Primary DI
06970966660140
Brand
GENTEC®
Company
GENTEC(SHANGHAI)CORPORATION
Model
FM197A-15L
Device description
Flowmeter, 15L Series, Oxygen or Air, Aluminum
Published
2023-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970966660140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970966660140069709666601406970966660140

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
06970966665688GENTEC®193M Series2026-10-16
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
06970966663929GENTEC®FM197A -70L-HS 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101624248OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101624385OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101624392OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101624408OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101624415OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101629236OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101629243OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101629250OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101629922OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101629939OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101630379OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101630386OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101630454OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101630461OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101630683OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631093OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631109OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631116OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631123OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631130OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631147OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631154OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631161OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631178OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631185OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631192OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631208OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631215OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631222OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631239OhioOHIO MEDICAL, LLCCAX2026-10-22