FDA.reportPublic FDA data

NOxBOXi

Primary DI
95060541640149
Brand
NOxBOXi
Company
NOXBOX LTD
Model
CON158
Catalog number
NXBCON158
Device description
Single use connector 22M/15F-15M Gas Sampling Port
Published
2018-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171696000NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc.2018-10-02MRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
95060541640149PackageGS1999999999In Commercial Distribution
15060541640143PrimaryGS10
05060541640146Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
9506054164014995060541640149
1506054164014315060541640143
05060541640146050605416401465060541640146

GMDN Terms#

Term, Definition table
TermDefinition
Nitric oxide delivery unit, system-basedA mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure800 millibar1200 millibar
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure800 millibar1200 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-669-8368NoxiventUS@Praxair.com

Regulatory Flags#

DUNS number
220841986
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
05060541640078NOxBOXiNOXBOX-I TESTNXBNOXBOXI-TEST2018-11-05
25060541640072NOxBOXiNOXBOX-I TESTNXBNOXBOXI-TEST2018-11-05
15060541640112NOxBOXiFXS555NXBFXS5552018-11-05
15060541640129NOxBOXiFIL063NXBFIL0632018-11-05
15060541640136NOxBOXiFIL064NXBFIL0642018-11-05
15060541640143NOxBOXiCON158NXBCON1582018-11-05
05060541640030NOxBOXiNOXKIT-2-22NXBNOXKIT-2-222018-11-05
05060541640047NOxBOXiNOXKIT-2-15NXBNOXKIT-2-152018-11-05
05060541640054NOxBOXiNOXKIT-1-10NXBNOXKIT-1-102018-11-05
05060541640061NOxBOXiNOXKIT-2-12NXBNOXKIT-2-122018-11-05
05060541640085NOxBOXiNOXKIT-HFJVNXBNOXKIT-HFJV2018-11-05
95060541640118NOxBOXiFXS555NXBFXS5552018-11-05
95060541640125NOxBOXiFIL063NXBFIL0632018-11-05
95060541640132NOxBOXiFIL064NXBFIL0642018-11-05
15060541640167NOxBOXiNOXKIT-EMERNXBNOXKIT-EMER2018-11-05
05060541640016NOxBOXiNOXBOX-INXBNOXBOX-I2018-11-05
05060541640023NOxBOXiNOXDC-INXBNOXDC-I2018-11-05
25060541640034NOxBOXiNOXKIT-2-22NXBNOXKIT-2-222018-11-05
25060541640041NOxBOXiNOXKIT-2-15NXBNOXKIT-2-152018-11-05
25060541640058NOxBOXiNOXKIT-1-10NXBNOXKIT-1-102018-11-05

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Primary DI, Brand, Company table
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B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
00817770025856MaxBlend2MAXTEC, LLCCCL2024-08-14
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCCL2024-05-13
10190752191235Vital Signs™AirLife Finland OyCCL2023-05-30
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCCL2023-04-19
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00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCCL2023-04-19
00195278524089NAGE Healthcare Finland OyCCL2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCCL2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCCL2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyCCL2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
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00840682146791NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682104302NAGE Healthcare Finland OyCCL2022-03-07
10190752111349Vital Signs™Vyaire GmbHCCL2021-04-02
10190752143777Vital Signs™AirLife Finland OyCCL2021-03-05
10190752143784Vital Signs™AirLife Finland OyCCL2021-03-05
10190752143791Vital Signs™AirLife Finland OyCCL2021-03-05
10190752140844Vital Signs™AirLife Finland OyCCL2021-01-28
10190752140912Vital Signs™AirLife Finland OyCCL2021-01-28
10190752141827Vital Signs™AirLife Finland OyCCL2021-01-28