FDA.report

SAMPLING LINE FILTER, .8 Micron

Primary DI
00612649190945
Brand
SAMPLING LINE FILTER, .8 Micron
Company
King Systems Corporation
Model
7019
Catalog number
7019
Device description
SAMPLING LINE FILTER, .8 Micron
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications

CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612649111940PackageGS1100In Commercial Distribution
00612649190945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649111940006126491119406126491119400612649111940
00612649190945006126491909456126491909450612649190945

GMDN Terms

TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
009299017
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00612649214559UNIVERSAL F® FLEX2®AF476-6121ZAF476-6121Z2023-01-18
00612649100494CORRUGATED TUBING1011001011002022-12-18
00612649185224WASHINGTON CONNECTOR178517852022-12-08
00612649106779100 FT 22MM ULTRA FLEX® TUBING30010300102022-12-18
00612649121758100 FT., 6" 22MM SEGMENTEDB101100B1011002022-12-08
00612649149103RE'SPOSABLE® F2®MD121MD1212022-12-08
0061264915411418" REUSABLE TUBINGMD124MD1242022-12-08
00612649190242BREATHING BAG514551452022-12-08
00612649190181BREATHING BAG513751372022-12-08
00612649190211BREATHING BAG514151412022-12-08
00612649190198BREATHING BAG513951392022-12-08
00612649190136BREATHING BAG510951092022-12-08
00612649190112BREATHING BAG510751072022-12-08
00612649190105BREATHING BAG510551052022-12-08
00612649190129BREATHING BAG510851082022-12-08
00612649190099BREATHING BAG510151012022-12-08
00612649190068BREATHING BAG509750972022-12-08
00612649190075BREATHING BAG509850982022-12-08
00612649190082BREATHING BAG509950992022-12-08
00612649190044BREATHING BAG509450942022-12-08

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