Microstream Advance Adult Nasal CO2 Filter Line - Adt Nsl CO2 Line LTerm - Philips Medical Systems Hsg

Duns Number:790605856

Device Description: Adt Nsl CO2 Line LTerm

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More Product Details

Catalog Number

989803204621

Brand Name

Microstream Advance Adult Nasal CO2 Filter Line

Version/Model Number

Adt Nsl CO2 Line LTerm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181624,K181624

Product Code Details

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Device Record Status

Public Device Record Key

43122720-5953-4d6e-9a19-0d5c4dbea431

Public Version Date

October 28, 2022

Public Version Number

4

DI Record Publish Date

July 23, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS MEDICAL SYSTEMS HSG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 323
3 A medical device with high risk that requires premarket approval 36
U Unclassified 1