Primary Device ID | 00382830047920 |
NIH Device Record Key | c2487135-3e59-44d1-9e07-38afc5be9451 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Keypoint |
Version Model Number | 9013S0352 |
Catalog Number | 9013S0352 |
Company DUNS | 896421240 |
Company Name | NATUS MANUFACTURING LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00382830047920 [Primary] |
GXY | Electrode, Cutaneous |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-03-21 |
Device Publish Date | 2019-03-13 |
00382830053280 | Electr. input connector, 5p DIN 10 cm cable |
00382830051101 | Keypoint.NET |
00382830051095 | Network Connection for Keypoint System |
00382830051088 | Movement Related Potentials |
00382830051071 | Visual Evoked Potentials |
00382830051064 | Macro EMG |
00382830051057 | Single Fiber EMG |
00382830051040 | RR-Analysis |
00382830051033 | Somatosensory Evoked Potentials |
00382830051026 | Auditory Evoked Potentials |
00382830051019 | EMG Monitor, Spectrum Analysis |
00382830051002 | EMG Monitor for Keypoint.NET |
00382830050999 | VIR SOFTWARE, EDX - EMG/ NCS |
00382830050982 | KPNET v2.2x Upgrade |
00382830050975 | M Response Analysis for Keypoint.NET |
00382830050968 | Quantitative EMG for Keypoint.NET |
00382830050852 | KeypointNET Software 2.40 |
00382830050760 | 4-ch. Amplifier |
00382830050487 | 3-ch. Focus Amplifier |
00382830050470 | Hush Yoke cable, 4 meter |
00382830050449 | Multi CC Stim |
00382830050432 | Single CC Stim |
00382830050425 | Tendon Hammer |
00382830050418 | Tubal Insert Earphones |
00382830050401 | Calibrated Headset |
00382830050395 | 8-ch. Amplifier |
00382830050388 | 6-ch. EP Amplifier |
00382830050371 | 6-ch. Amplifier |
00382830050340 | Review Software (10+ Users Floating License) |
00382830050333 | Review Software (10 Users Floating License) |
00382830050326 | Review Software (5 Users Floating License) |
00382830050302 | Review Software (Single User) |
00382830050296 | Focus Main Unit |
00382830050081 | Keypoint Focus Workstation |
00382830050043 | Keypoint Focus Notebook System |
00382830049955 | Keypoint Focus Module |
00382830049849 | Natus Pattern Stimulator 22' TFT Display with Connection Kit |
00382830049788 | Keypoint G4 (Workstation) |
00382830049665 | Active Handgrip, One button model |
00382830049450 | Keypoint Focus Main Unit |
00382830049214 | Demo HaspKey (USB Dongle) |
00382830049160 | Isolating Transformer, 230V |
00382830049153 | Isolating Transformer, 115V |
00382830049139 | 3-ch. Amplifier |
00382830049122 | AMPLIFIER ARM, SINGLE |
00382830049078 | Goggles for VEP including 5m Cable |
00382830049061 | Advanced Stimulation Handgrip |
00382830048347 | Electrode cable 13P87 |
00382830048033 | Electrode cable 32" red, clip x 1.5mm |
00382830047920 | HUSH bar electrode |