Somanetics

Primary DI
10817357020547
Brand
Somanetics
Company
HYGIA HEALTH SERVICES, INC.
Model
SAFB-SM
Device description
Cerebral/Somatic Oximetry Adult Sensor 
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NMDOximeter, Tissue Saturation, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NMDOximeter, Tissue Saturation, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100523000ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USAHygia Health Services, Inc.2010-05-04NMD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30817357020541PackageGS120Not in Commercial Distribution
10817357020547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081735702054130817357020541
1081735702054710817357020547

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeter sensor, reprocessedA photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Regulatory Flags#

DUNS number
177939027
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817357021704Mabis10-428-0802016-09-24
10817357021797Mabis10-426-0202016-09-24
10817357021940Mabis10-426-0802016-09-24
10817357021957Mabis10-428-0102016-09-24
10817357021995Mabis10-428-0202016-09-24
10817357021179Stryker5921-034-2352018-05-04
10817357021261Zimmer60-7070-1032018-01-15
10817357021278Zimmer60-7070-1062018-01-15
10817357021438Stryker5921-218-2352018-05-04
10817357021469Zimmer60-7070-1042018-03-02
10817357021575Zimmer60-7070-1052018-01-15
10817357021735Stryker5921-218-1352018-03-03
10817357021841Stryker5921-034-1352018-03-02
10817357021919Stryker5921-024-2352018-05-04
10817357022022Stryker5921-044-2352018-05-04
10817357022169Stryker5921-030-1352018-03-02
10817357022350Stryker5921-018-1352018-02-16
10817357022435Zimmer60-7075-1032018-02-16
10817357022442Zimmer60-7075-1062018-02-16
10817357022459Zimmer60-7075-1052018-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067028709BurstDR™ST. JUDE MEDICAL, INC.NMD2018-03-15
10817357022190SomaneticsHYGIA HEALTH SERVICES, INC.NMD2017-02-04
30817357022194SomaneticsHYGIA HEALTH SERVICES, INC.NMD2017-02-04
30817357020541SomaneticsHYGIA HEALTH SERVICES, INC.NMD2016-09-22