FDA.reportPublic FDA data

M91227-25, Medikro® Grip

Primary DI
06420099000691
Brand
M91227-25, Medikro® Grip
Company
Medikro Oy
Model
M91227
Published
2018-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06420099000691PrimaryGS10
06420099001018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06420099000691064200990006916420099000691
06420099001018064200990010186420099001018

GMDN Terms#

Term, Definition table
TermDefinition
Cable/lead holderA device intended to hold medical cables/leads, primarily those that convey electricity and electrical signals. It is typically used in conjunction with an electrocardiograph (ECG) or an electromyograph (EMG) to support and stabilize electrical cable/leads used during patient treatment. It is typically designed as a jointed, adjustable arm with a mounting fixture, that attaches to the recording device, and a holder at the distal end to hold the cables/leads near the patient; it is intended to help organize and protect the cables/leads to prolong their life and help prevent patient disconnection. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
369263660
Device count
25
Premarket exempt
true
Lot or batch
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
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
06420099000387M9474, Medikro® Calibration Syringe, 3000 mlM94742018-07-13

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