Natus

GUDID 00382830037327

EDX 8 channel Amplifier

NATUS NEUROLOGY INCORPORATED

Electromyograph

• Primary Device ID: 00382830037327
• NIH Device Record Key: d92c11c4-bd05-4fc9-8ebb-8ca68b4054a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natus
• Version Model Number: 515-016100
• Company DUNS: 874257488
• Company Name: NATUS NEUROLOGY INCORPORATED
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830037327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112052

FDA Product Code

• IKN: Electromyograph, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Natus ]

• 00382830043595: LRU/VS ES-8 AMPLIFIER
• 00382830043588: LRU VikingQuest Base with Auditory F Part
• 00382830043571: LRU/VS EA-2 AMPLIFIER SHLD/HSG
• 00382830043564: KIT, AMPLIFIER 2 CH-SPARE
• 00382830043557: AMPLIF'R,10 CHAN EMG UNTESTED
• 00382830043540: AMPLIF'R,5CHANNEL EMG-UNTESTED
• 00382830043526: PLINTH ASSY NON-EP SYSTEM
• 00382830043519: PLINTH ASSY EP SYSTEM
• 00382830043502: IOM STIMULATOR ASSY
• 00382830043496: AUDIOMETRIC HEADPHONES GA
• 00382830043472: UltraPro S100 Laptop PC - Windows 7 Professional
• 00382830043465: VikingQuest Laptop PC - Windows 7 Professional
• 00382830043212: Nicolet Laptop PC
• 00382830043199: Nicolet Desktop PC
• 00382830041805: SOFT/EEG NICOLET-ONEV4.1.3B971
• 00382830041799: ASSY/LRU SONARA LCD & TOUCH SC
• 00382830041751: Vista Software CD
• 00382830041744: SOFT/VS CD V12.1.0
• 00382830041621: Endeavor CR Mini Control Panel
• 00382830041591: ELC/NCS BAR ELEC/100 PK
• 00382830041560: EMG USB Control Panel
• 00382830041492: Disposable Pre-Gelled Surface Electrodes, 20mm X 25mm, 2m lead, 1.5mm female touchproof
• 00382830041478: Disposable Pre-Gelled Surface Electrodes, 20mm X 25mm, 1.5m lead, 1.5mm female touchproof
• 00382830041454: Disposable Pre-Gelled Surface Electrodes, 20mm X 25mm, 1m lead, 1.5mm female touchproof
• 00382830041430: Disposable Pre-Gelled Surface Electrodes, 20mm X 25mm, 8cm lead, 0.7mm male touchproof
• 00382830041355: Disposable Pre-Gelled Surface Electrodes, 15mm X 20mm, 1.5m lead, 1.5mm female touchproof
• 00382830041331: Disposable Pre-Gelled Surface Electrodes, 15mm X 20mm, 8cm lead, 0.7mm male touchproof
• 00382830041058: ELC/DISP DISK W 1M LEAD 60,DIN
• 00382830041041: GRD PLATE 1.0M LEAD 24 POCH/PK
• 00382830041034: ELC/EXT.CBL 2.0M DIN 6PK
• 00382830041027: ELC/GROUND PLATE .75M DIN
• 00382830041010: ELC/BAR 1.0M, DIN (1 EACH)
• 00382830041003: ELC/BAR W/FELT TIP 1.0M,DIN
• 00382830040990: ELC/SMALL STIM W/DIN
• 00382830040969: ELC/EAR CLIP WDIN S/C 10MM 2PK
• 00382830040952: GRD STRAP AD 54CM 1.25M LEAD D
• 00382830040914: ELC/DISP TAB W/DIN 48 PER PACK
• 00382830040907: CBL/1 TWISTED PAIR EXT CBL 1M
• 00382830040846: ELC/DISP DISK W 2M LEAD 60,DIN
• 00382830040839: GRD PLATE 2.0M LEAD 24 POCH/PK
• 00382830040815: ELC/EEG GLD 10MM 1.5MTF 12PK DIN
• 00382830040808: ELC/EEG SIL 10MM 1.5M TFD 12PK
• 00382830040785: ELC/DISP 3 DISK 1M 24PCH/BOX D
• 00382830040778: ELC/EEG GLD 10MM 1MTF 12PK DIN
• 00382830040761: ELC/EEG SLVR 10MM 1MTF 12PK DIN
• 00382830040747: ELC/DISP DSK 2R2B 1.5M 24PCH D
• 00382830040723: ELC/DISP 2DSK 1GRND 1M 24PCH D
• 00382830040716: ELC/PED ELC GRND STRAP 1.25M D
• 00382830040686: ELC/ALLIG CLIP 1.25M RED&BLK D
• 00382830040679: ALLI CLP GRD 1.25M LEAD DIN CO