O.B - TOOLS LTD

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Monitoring, Perinatal (HGM) (3) Uterine Electromyographic Monitor (OSP) (3)

Premarket Exempt

Clear

TrueLabor Maternal Unit - 07290016406016 Catalog Number : FG0001(X)

Device Description : TrueLabor's Maternal Unit is connected via a proprietary connector to the Embrac TrueLabor's Maternal Unit is connected via a proprietary connector to the Embrace electrode array. The MU acquires EMG signals and provides Fetal Heart Rate and Uterine Activity are transmitted via Bluetooth. The unit contains a Li-Ion rechargeable battery.

Device Class : 2

Duns Number: 534149604

Premarket Exempt : No

Product Code : HGM, OSP

Prescription Use : Yes

Device Count : 1

TrueLabor Monitor Adapter - 07290016406023 Catalog Number : FG0002(X)

Device Description : The TrueLabor's Monitor Adapter for the hospital maternal/fetal monitoring syste The TrueLabor's Monitor Adapter for the hospital maternal/fetal monitoring system. The corresponding Maternal Unit transmits the uterine activity/fetal heart rate information via Bluetooth to the MONITOR ADAPTER which transfers it to the hospital monitor or directly to the hospital IT system.

Device Class : 2

Duns Number: 534149604

Premarket Exempt : No

Product Code : HGM, OSP

Prescription Use : Yes

Device Count : 1

EmbraceTM Electrodes Array (L) - 07290016406030 Catalog Number : FG0003(X)

Device Description : Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined wi Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.

Device Class :

Duns Number: 534149604

Premarket Exempt : No

Product Code : OSP, HGM

Prescription Use : Yes

Device Count : 1

Previous 1 Next