FDA.reportPublic FDA data

Universal Bite Block, Adult

Primary DI
00850008733086
Brand
Universal Bite Block, Adult
Company
B&B Medical Technologies
Model
11160
Catalog number
11160
Device description
Adult Endotracheal Tube Bite Block, 50 Units
Published
2019-12-13
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
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008733086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008733086008500087330868500087330860850008733086

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic bite block, basic, single-useA device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. 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
00850008733208BODAI NEO2-SAFE11105111052023-07-06
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
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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