FDA.reportPublic FDA data

MR Patient Care SpO2 Grip Starter Kit (20 piece)

Primary DI
10884838101026
Brand
MR Patient Care SpO2 Grip Starter Kit (20 piece)
Company
Philips Ds North America LLC
Model
SpO2 Grip Starter Kit (20 piece)
Catalog number
989803167111
Device description
Starter pack for the Quick Connect SpO2 Sensor (989803161991) that includes 5 each of Adult, Pediatric, Infant and Neonatal disposable grips.
Published
2021-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884838101026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088483810102610884838101026

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). The is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure57 KiloPascal102 KiloPascal
Storage Environment Atmospheric Pressure429 Millimeter of Mercury765 Millimeter of Mercury
Storage Environment Atmospheric Pressure570 millibar1020 millibar
Storage Environment Humidity5 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
013649151
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838072657Invivo989603208432016-09-23
00884838072664Invivo989603203332016-09-23
00884838072756Invivo989603203272016-09-23
00884838072763Invivo989603203282016-09-23
00884838072770Invivo989603208422016-09-23
00884838072787Invivo989603204212016-09-23
00884838072794Invivo989603203302016-09-23
00884838072800Invivo989603203312016-09-23
00884838072817Invivo989603203322016-09-23
00884838100114Invivo4535-302-233312020-04-17
00884838066991Invivo7840112016-09-23
00884838072558Invivo989603205282016-09-23
00884838072565Invivo989603203012016-09-23
00884838072572Invivo989603203022016-09-23
00884838073456Invivo989603208782016-09-23
00884838073463Invivo989603208792016-09-23
00884838081543Invivo7840122016-09-23
00884838082885Invivo989603210042017-07-28
00884838083592Invivo7840012016-09-23
00884838098459PhilipsdS FLEX-S 1.5T4598017299712021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
06946725571705APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880031UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
00840118620987Endure IndustriesENDURE INDUSTRIESDQA2026-08-14
06946725572078APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572085APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572092APKAPK Technology Co.,Ltd.DQA2026-08-14
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09