FDA.reportPublic FDA data

6' NAFION LINE

Primary DI
00612649191126
Brand
6' NAFION LINE
Company
King Systems Corporation
Model
7153
Catalog number
7153
Device description
NAFION LINE
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612649112404PackageGS120In Commercial Distribution
00612649191126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649112404006126491124046126491124040612649112404
00612649191126006126491911266126491911260612649191126

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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Primary DI, Brand, Company table
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20889483300135Respan®SUNMED, LLCCAI2026-02-11
46923980110359N/AGaleMed Xiamen Co., Ltd.CAI2026-02-05
M368H0678972HAUSTEDGF HEALTH PRODUCTS, INC.CAI2025-10-31
00612649214559UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649130972JACKSON REESKing Systems CorporationCAI2023-01-18
00612649214047UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214030UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214078UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214092UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214115UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214139UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214153UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18