FDA.reportPublic FDA data

BODAI NEO2-SAFE

Primary DI
00850008733208
Brand
BODAI NEO2-SAFE
Company
B&B Medical Technologies
Model
11105
Catalog number
11105
Device description
Infant Circuit Manifold, 50 units
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00850008733208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008733208008500087332088500087332080850008733208

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
829743579
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008733147ET Tape 11025110252023-07-06
00850008733154ET Tape 11020110202023-07-06
00850008733215BODAI NEO2-SAFE11100111002023-07-06
00850008733260Baby Tape Plus25395253952023-07-06
00850008733277Baby Tape Plus25390253902023-07-06
00850008733185Trachstay11270112702020-03-24
00850008733130Locktite11090110902020-01-29
00850008733093Trachguard11250112502020-01-20
00850008733109Trachguard11255112552020-01-20
00850008733116ET Tape II11015110152020-01-20
00850008733123ET Tape II11010110102020-01-20
00850008733086Universal Bite Block, Adult11160111602019-12-13
00850008733062Stabiltube11060110602019-11-08
00850008733079Stabiltube11065110652019-11-08
00850008733048Accutach Flow Sensor25250252502019-07-18
00850008733031B&B Bubbler25312253122019-07-12
00850008733055B&B Bubbler25324253242019-07-12
00850008733024HOPE Nebulizer11310113102019-05-17
00850008733000HOPE Nebulizer - Adult Kit11320113202019-05-13
00850008733017HOPE Nebulizer - Pediatric Kit11330113302019-05-13

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