FDA.reportPublic FDA data

GENOSYL®

Primary DI
00850000962095
Brand
GENOSYL®
Company
VERO BIOTECH INC.
Model
601954-01
Catalog number
601954-01
Device description
GENOSYL DS Bunnell Adapter
Published
2020-09-14
Public version status
Update
Distribution status
Not 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
BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000962095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000962095008500009620958500009620950850000962095

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(770)910-2319Al.Jacks@vero-biotech.com
+1(678)661-5721Robyn.McClure@Vero-Biotech.com

Regulatory Flags#

DUNS number
872672477
Device count
1
DM exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000962330GENOSYL®602524-01602524-012026-05-06
00850000962347GENOSYL®602013-04602013-042026-05-06
00850000962484GENOSYL®601758-04601758-042026-05-06
00850000962019GENOSYL®602747-01602747-012023-07-24
00850000962316GENOSYL®602716-01602716-012023-07-24
00850000962125GENOSYL®602039-01602039-012020-09-14
00850000962132GENOSYL®602069-01602069-012020-09-14
00850000962156GENOSYL®601746-02601746-022020-09-14
00850000962088GENOSYL®601758-02601758-022020-06-15
00850000962033GENOSYL®6016906016902020-05-14
00850000962262GENOSYL®600943-01600943-012023-10-06
00850000962279GENOSYL®601745-01601745-012023-10-06
00850000962309GENOSYL®601970-01601970-012023-10-06
00850000962323GENOSYL®601503-01601503-012023-10-06
00850000962064GENOSYL®6019556019552023-07-24
00850000962194GENOSYL®6024896024892023-03-16
00850000962170GENOSYL®602166-01602166-012023-03-14
00850000962286GENOSYL®601743-01601743-012023-10-06
00850000962293GENOSYL®601747-01601747-012023-10-06
00850000962101GENOSYL®602001-01602001-012023-07-24

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