FDA.reportPublic FDA data

BLOCK F. EEG REF ID CONVERSION

Primary DI
04049098007887
Brand
BLOCK F. EEG REF ID CONVERSION
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
5954859
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMCReduced- 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
04049098007887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098007887040490980078874049098007887

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical cable adaptorA small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788289952
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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04048675780212Infinity R50-S RecorderMS412172025-02-19
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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
04049098001878Infinity CentralStation Wide (confi)MS268002015-10-24
04049098000185Resuscitaire Birthing Room Warmer (WBR82)MU205122015-10-24
04049098000192TI500 Globetrotter Neonatal Transport SystemMU205082015-10-24
04049098000215Resuscitaire Radiant Warmer (RW82, RW82 VHA)MU205032015-10-24
04049098000413Restraint strap, replacement, carton of 10MU060112015-10-24

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