FDA.reportPublic FDA data

Microstream Advance Neonatal-Infant Intubated CO2 Filter Line

Primary DI
20884838093137
Brand
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line
Company
Philips Medical Systems Hsg
Model
Neo/Inf Intub CO2 Line LTerm
Catalog number
989803204531
Device description
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line, Extended Duration
Published
2021-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181467000Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter LineOridion Medical 1987 , Ltd.2019-02-08CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884838093137PrimaryGS10
00884838093133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088483809313720884838093137
00884838093133008848380931338848380931330884838093133

GMDN Terms#

Term, Definition table
TermDefinition
Carbon-dioxide-sampling nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790605856
Device count
25
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838048089Philips12-Lead Patient Cable (AAMI), Std Length9898031849312023-05-25
00884838048102Philips12-Lead Patient Cable (AAMI), Long9898031849512023-05-25
00884838012974NOUNPW CBL Complete Lead Set AAMI9898031516312016-12-06
00884838012981NOUNPW CBL Complete Lead Set IEC9898031516412016-12-06
00884838012998NOUNChest Lead Set, AAMI/IEC9898031516712016-12-06
00884838013001NOUNLong Chest Lead Set (Both AAMI and IEC)9898031516912016-11-11
00884838013025NOUNLimb Lead Set (Both AAMI and IEC)9898031517112016-11-03
00884838013032NOUNLong Limb Lead Set (Both AAMI and IEC)9898031517312017-06-07
00884838013049NOUNTC ADDITIONAL LEADS KIT: AAMI9898031517512017-05-11
00884838013056NOUNTC ADDITIONAL LEADS KIT: IEC9898031517612017-04-12
00884838014978NOUNLong Complete Lead Set AAMI9898031516512017-01-26
00884838014985NOUNPW CBL Long Complete Lead Set IEC9898031516612017-01-04
00884838014992NOUNTC ADDITIONAL LONG LEADS KIT: AAMI9898031517712017-11-08
00884838015005NOUNTC ADDITIONAL LONG LEADS KIT: IEC9898031517812017-04-28
00884838025479NOUNPW TC20 10-Lead Patient Cable IEC9898031758912016-10-06
00884838025486NOUNPW TC20 10-Lead Patient Cable AHA9898031759012016-11-23
00884838025493NOUNPW TC20 Long 10-Lead Patient Cable IEC9898031759112016-11-03
00884838025509NOUNPW TC20 Long 10-Lead Patient Cable AHA9898031759212016-10-06
00884838029118NOUN12L Leadset, Grabber, AAMI9898031801212016-12-19
00884838029125NOUN12L Leadset, Grabber, IEC9898031801312016-11-24

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