FDA.reportPublic FDA data

CAMINO®

Primary DI
00382830048866
Brand
CAMINO®
Company
NATUS MEDICAL INCORPORATED
Model
026950
Catalog number
026950
Device description
14.4 V Lithium Ion Battery
Published
2020-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDevice, Monitoring, Intracranial Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121573000INTEGRA CAMINO ICP MONITORIntrgra Lifesciences Corporation2012-09-10GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780121893PreviousGS10
00382830048866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178012189310381780121893
00382830048866003828300488663828300488660382830048866

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder or container intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. It is typically used during a transport situation (e.g., a neonatal incubator), or when the device is designed to power a cordless devices (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-356-0007Madison.Helpdesk@Natus.com

Regulatory Flags#

DUNS number
081325959
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830008365Bio-logicDisposable Snap Electrodes101600; 1016032016-12-30
00382830045247Echo-Screen III ProEchoScreen III Refurbished, TEOAE with barcode023480R2020-02-20
00382830045278Echo-Screen III ProEchoScreen III Refurbished, DPOAE with barcode023481R2020-02-20
00382830045292Echo-Screen III ProEchoScreen III Refurbished, ABR with barcode023482R2020-02-20
00382830045315Echo-Screen III ProEchoScreen III Refurbished, TEOAE & DPOAE with bar023483R2020-02-20
00382830045339Echo-Screen III ProEchoScreen III Refurbished, TEOAE & ABR with barco023484R2020-02-20
00382830045353Echo-Screen III ProEchoScreen III Refurbished, DPOAE & ABR with barco023485R2020-02-20
00382830000727NATUS MEDICAL2032002016-10-26
00382830000734Bio-logicOAE Foam Tip Pediatric203201, 294252016-12-30
00382830000741Bio-logicOAE Foam Tip Adult203202, 294272017-03-31
00382830000758Bio-logicOAE Tree Tip203208, 294212017-03-31
00382830000765Bio-logicOAE Tree Tip Preemie2032092017-03-31
00382830000772Bio-logicOAE Jumbo Tip2032102017-03-31
00382830000789Bio-logicOAE Foam Tip Pediatric203211, 294262016-12-30
00382830000796Bio-logicOAE Foam Tip Adult203212, 294282017-03-31
00382830000819Bio-logicOAE Tree Tip203218, 294222017-03-31
00382830000826Bio-logicOAE Tree Tip Preemie2032192017-03-31
00382830000833Bio-logicOAE 6mm Tip203333, 294232016-12-30
00382830000840Bio-logicOAE 6mm Tip203353, 294242016-12-30
00382830000871Natus Silver Disc Electrode Silicone1010012017-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760409447055SOPHYSASOPHYSAGWM2026-06-08
03760409447093SOPHYSASOPHYSAGWM2026-06-08
07908398200008BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2026-05-08
00850013266272IRRAflow Cranial Access BoltClearpoint Neuro, Inc.GWM2025-07-24
00763000281243Exacta Pole Clamp with laser levelMEDTRONIC PS MEDICAL, INC.GWM2025-02-17
00763000281229Exacta Pole Clamp with laser levelMEDTRONIC PS MEDICAL, INC.GWM2025-02-16
00763000467401NAMEDTRONIC PS MEDICAL, INC.GWM2024-06-01
00763000406073BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-03-31
20763000467344NAMEDTRONIC PS MEDICAL, INC.GWM2024-03-01
20763000467351NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467382NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467399NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000431259BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000529307BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000529369BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000572877BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-25
00850013266203IRRAflow Tube SetClearpoint Neuro, Inc.GWM2023-11-02
00763000624774Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000624781Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000624798Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000428723Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428747Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428754Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428761Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428778Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000431273Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-13
20763000431307N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395971Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395988N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07