FDA.reportPublic FDA data

EEG Leads, 0.6m, reusable, 9 pcs

Primary DI
04049098008013
Brand
EEG Leads, 0.6m, reusable, 9 pcs
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
5947804
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991012000SIEMENS INFINITY EEG PODSiemens Medical Solutions USA, Inc.1999-06-24OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049098008013PrimaryGS10
04049098058223Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098008013040490980080134049098008013
04049098058223040490980582234049098058223

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004372437info@draeger.com

Regulatory Flags#

DUNS number
788289952
Device count
9
Manufacturing date on label
true

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04049098096423SHP EXC M300+MS336592025-02-19
04049098099264S/W SUB VF9.0 GatewayMS400462025-02-19
04049098099608Gateway Software Server VF9.0MS400482025-02-19
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04049098000185Resuscitaire Birthing Room Warmer (WBR82)MU205122015-10-24
04049098000192TI500 Globetrotter Neonatal Transport SystemMU205082015-10-24
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