FDA.reportPublic FDA data

INVOS

Primary DI
20884521810379
Brand
INVOS
Company
Covidien LP
Model
CNN/SNN
Device description
Infant Regional Saturation Sensor Cerebral/Somatic - Neonatal
Published
2021-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUDOximeter, tissue saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091224000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091224000OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-SSomanetics Corp.2009-07-09MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521810379PackageGS110In Commercial Distribution
30884521810376PackageGS18In Commercial Distribution
10884521810372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452181037920884521810379
3088452181037630884521810376
1088452181037210884521810372

GMDN Terms#

Term, Definition table
TermDefinition
Cerebral oximeter sensor, single-useA photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near-infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. It connects to a cerebral oximeter via a fibreoptic cable and typically consists of a single/dual adhesive sensing strip. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure47 KiloPascal108 KiloPascal
Handling Environment Atmospheric Pressure61.6 KiloPascal107.5 KiloPascal
Handling Environment Atmospheric Pressure62 KiloPascal108 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure46.5 KiloPascal107.5 KiloPascal
Storage Environment Atmospheric Pressure47 KiloPascal108 KiloPascal
Storage Environment Atmospheric Pressure62 KiloPascal108 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyMUD2026-04-15
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00690103219609VitaWaveEdwards Lifesciences LLCMUD2025-09-10
00690103219616ForeSight IQEdwards Lifesciences LLCMUD2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCMUD2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCMUD2025-07-11
10884521845985INVOSCovidien LPMUD2025-07-03
00690103217957HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
10884521845039INVOSCovidien LPMUD2025-02-08
20884521845036INVOSCovidien LPMUD2025-02-08
00690103218879HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103211313ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211320ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211337ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211318ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211325ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211332ForeSightEdwards Lifesciences LLCMUD2024-08-26
10884521701243INVOSCovidien LPMUD2024-04-14
10884521557048INVOSCovidien LPMUD2024-04-14
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00690103217124HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218848HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218855HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218862HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
10884521824409INVOSCovidien LPMUD2023-11-03
10884521824416INVOSCovidien LPMUD2023-11-03