FDA.reportPublic FDA data

M9474, Medikro® Calibration Syringe, 3000 ml

Primary DI
06420099000387
Brand
M9474, Medikro® Calibration Syringe, 3000 ml
Company
Medikro Oy
Model
M9474
Published
2018-07-13
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
BXWCalibrator, Volume, Gas

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXWCalibrator, Volume, GasAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06420099000387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06420099000387064200990003876420099000387

GMDN Terms#

Term, Definition table
TermDefinition
Spirometer/pulmonary function analyser syringeA dedicated piston-in-barrel used for injecting small volumes of accurately measured amounts of gas into a spirometer, pulmonary function analyser, or other diagnostic pulmonary measuring/testing device for calibration or reference. It is typically a glass or plastic cylinder (barrel) and steel plunger (piston) with a finely graduated scale along the length of the cylinder. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
369263660
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094130348703554 Spirometer Kit (USB)M94682026-04-21
06420099000042M921, Medikro® SpiroStar DXM94702026-04-21
06420099000219703552 Spirometer Kit (Serial)M94712026-04-21
06420099000264M9242-100, SpiroSafe Disposable Flow TransducerM92422026-04-21
06420099000318703419 Disposable Flow Transducer QTY 100M9242-WA2026-04-21
06420099000325703418 Disposable Flow Transducer QTY 25M9242-WA2026-04-21
06420099000332703417 Disposable Flow Transducer QTY 4M9242-WA2026-04-21
06420099000448M929, Medikro® SpiroStar USBM94792026-04-21
06420099000622M9242-SP-90, SpiroSafe Disposable Flow TransducerM92422026-04-21
06420099000554M9256, SpiroSafe Disposable Flow TransducerM9256-1002018-07-13
06420099000677M9227, Nose ClipM92272018-07-13
06420099001117M9256-PCD, Disposable Flow Transducer, 100 pcsM9256-PCD-1002019-11-29
06420099000561M9256, SpiroSafe Disposable Flow TransducerM9256-SP-902018-07-13
06420099000691M91227-25, Medikro® GripM912272018-07-13
06420099000820M913, Medikro® NanoM94872018-07-13
06420099000837M915, Medikro® ProM94882018-07-13
06420099000851M914, Medikro® PrimoM94922018-07-13
06420099001094M915-PCD, PCD Spirometer KitM9488-PCD2019-11-29
06420099001087M915-PCD, PCD Spirometer KitM9488-PCD2019-11-29
06420099001124M9264-PCD-200, Pressure TubeM9264-PCD-2002019-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008171360277395530 3L SYRINGEHANS RUDOLPH, INC.BXW2026-05-01
008171360277465530 3L SYRINGEHANS RUDOLPH, INC.BXW2026-05-01
34250892907407JaegerJaeger Medical GmbHBXW2025-07-24
34250892907421JaegerJaeger Medical GmbHBXW2025-07-24
04250892907413JaegerJaeger Medical GmbHBXW2025-07-23
04250892907888JaegerJaeger Medical GmbHBXW2025-07-23
008170810279143 Liter Aluminum Calibration Syringe w/ AdapterA-M SYSTEMS, LLCBXW2024-11-07
008171360276855530 3L SYRINGEHANS RUDOLPH, INC.BXW2024-07-02
008171360276785530 3L SYRINGEHANS RUDOLPH, INC.BXW2024-02-13
008171360276615570 3L SYRINGEHANS RUDOLPH, INC.BXW2023-11-08
008171360276545570 3L SYRINGEHANS RUDOLPH, INC.BXW2023-08-21
008171360276475570 3L SYRINGEHANS RUDOLPH, INC.BXW2023-08-17
008571750060673L Calibration SyringeVECTRACOR INCBXW2023-06-07
00817081027594Syringe, Calibration, Adj. Vol., AluminumA-M SYSTEMS, LLCBXW2023-05-17
008171360270435540 1L SYRINGEHANS RUDOLPH, INC.BXW2023-01-05
008171360270365570 3L SYRINGEHANS RUDOLPH, INC.BXW2022-12-16
008171360269095530 3L SYRINGEHANS RUDOLPH, INC.BXW2022-08-08
008171360269165530 3L SYRINGEHANS RUDOLPH, INC.BXW2022-08-08
008171360268795530 3L SYRINGEHANS RUDOLPH, INC.BXW2022-05-16
008171360268005570 3L SYRINGEHANS RUDOLPH, INC.BXW2022-03-08
04250892906645VyaireJaeger Medical GmbHBXW2021-11-15
008170810271053 Liter Aluminum Calibration SyringeA-M SYSTEMS, LLCBXW2021-10-06
008171360267495530 3L SYRINGEHANS RUDOLPH, INC.BXW2021-09-23
00817081027051SYRINGE, CALIBRATION, ADJ. VOL., ALUMINUM,A-M SYSTEMS, LLCBXW2021-09-09
008171360267185570 3L SYRINGEHANS RUDOLPH, INC.BXW2021-08-06
04250892906102VyaireJaeger Medical GmbHBXW2021-07-16
04250892906140VyaireJaeger Medical GmbHBXW2021-07-16
34250892906110VyaireJaeger Medical GmbHBXW2021-07-16
34250892906127VyaireJaeger Medical GmbHBXW2021-07-16
34250892906134VyaireJaeger Medical GmbHBXW2021-07-16