FDA.reportPublic FDA data

Key Surgical Bite Blocks

Primary DI
00849771043843
Brand
Key Surgical Bite Blocks
Company
KEY SURGICAL, INC.
Model
EN-315
Device description
Bite Block, O2-CO2 monitoring and oxygen delivery, with strap
Published
2020-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNKEndoscopic Bite Block

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNKEndoscopic Bite BlockGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849771037200PrimaryGS10
00849771043843Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771037200008497710372008497710372000849771037200
00849771043843008497710438438497710438430849771043843

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic bite block, oxygenatingA dual-purpose device 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, and that simultaneously supports an oxygen (O2) line to provide the patient with an uninterrupted flow of O2 during and after endoscopy. The device also protects the tongue and teeth of the patient during endoscopy and may include a gas sample line that enables monitoring of the expired carbon dioxide (CO2) during the procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.541.7995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
Device count
25
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
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
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771052159NAES50ES502023-01-26
00849771048237NAK-Wire and Steinmann Pin DispenserKI710172025-08-11
00849771049036NAK-Wires and Steinmann PinsKI711312025-08-11
00849771049289NAK-Wires and Steinmann PinsKI711852025-08-11
00849771049500NAK-Wires and Steinmann PinsKI712532025-08-11
00849771048169NAK-Wire and Steinmann Pin DispensersKI710022025-04-30
00849771049012NAK-Wires and Steinmann PinsKI711242025-04-30
00849771049128NAK-Wires and Steinmann PinsKI711612025-04-30
60849771050416Electro LubeEL101EL1012025-04-24
00849771046356K-Wire and Steinmann Pin DispensersKI71042KI710422025-04-16
00849771046363K-Wire and Steinmann Pin DispensersKI71044KI710442025-04-16
00849771046370K-Wire and Steinmann Pin DispensersKI71046KI710462025-04-16
00849771046387K-Wire and Steinmann Pin DispensersKI71047KI710472025-04-16
00849771046394K-Wire and Steinmann Pin DispensersKI71048KI710482025-04-16
00849771013372Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
50849771050617NAK-Wire and Pin CoversC1092025-01-29
10724995225022Electro LubeEL201EL2012024-10-03
00849771048190NAK-Wire and Steinmann Pin DispensersKI710062024-10-03
00849771052562Key Surgical Pipe CleanersPC100CPC100C2024-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970800686855AltonAlton (Shanghai) Medical Instruments Co., Ltd.MNK2025-12-29
06973141950043EndocleanChangzhou Endoclean Medical Device Co.,LtdMNK2025-09-27
14897129991288CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
04897129991298CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
14897129991301CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
00194613120641MSI Precision Specialty InstrumentsMed Saver, Inc.MNK2025-08-01
16936603231125Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2025-06-23
00850025860048Breathe-EZMicro-tech UsaMNK2025-03-03
00858276007724Bite Block AdultMicro-tech UsaMNK2025-03-03
00858276007755Breathe-EZMicro-tech UsaMNK2025-03-03
06926839800595AnreiAnrei Medical(HZ) Co.,Ltd.MNK2025-01-07
40884389151151MEDLINEMEDLINE INDUSTRIES, INC.MNK2024-09-20
16970057578269Disposable Bite BlockJiangsu Vedkang Medical Science and Technology Co.,Ltd.MNK2024-08-20
14897129990755CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
14897129990762CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
14897129990724CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
14897129990731CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
00620974001072Bite BlockSouthmedic IncorporatedMNK2023-06-23
00620974001089Bite BlockSouthmedic IncorporatedMNK2023-06-23
00620974001683Bite BlockSouthmedic IncorporatedMNK2023-06-23
04719872108764Bite BlockENTER MEDICAL CORPORATIONMNK2023-06-19
06970401812165Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401812189Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401814077Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816132Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816149Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816156Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816538Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816828Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816835Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24