FDA.reportPublic FDA data

Medline

Primary DI
10884389129173
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJAA06
Catalog number
DYNJAA06
Device description
GAS SAMPLING LINE,10' MF,.06 ID W/FLT
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K946044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946044000DISPOSABLE GAS SAMPLING LINESCatheter Research, Inc.1994-12-27CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389129174PackageGS150In Commercial Distribution
10884389129173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438912917440884389129174
1088438912917310884389129173

GMDN Terms#

Term, Definition table
TermDefinition
Gas sampling line filter, single-useA screening device intended to be installed in a reusable gas sampling line or gas measuring instrument to remove and retain bacterial pathogens, and sometimes moisture, from the gas. It is designed to prevent a measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, bedside respiration monitor] and the system it is connected to (e.g., a breathing circuit) from becoming contaminated to reduce the risk of patient cross-contamination. Some types function as a water trap to help minimize damage to the measuring instrument from gas condensation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

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