FDA.reportPublic FDA data

AVANOS

Primary DI
00350770928098
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
23618
Catalog number
69103
Device description
Bite Block
Published
2020-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOGHOOD, OXYGEN, INFANT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOGHood, Oxygen, InfantAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830781000ENDO-GUARDJayco Pharmaceuticals1983-03-31FOG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00350770928098PrimaryGS10
10350770928095Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00350770928098003507709280983507709280980350770928098
1035077092809510350770928095

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

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
24
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31
00812120005120Game Ready* Ankle Wrap, Extra Large120008550590340-042026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, Right120008551590422-042026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, Left120008552590424-042026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, Right120008553590432-042026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, Left120008554590434-042026-07-31
00812120005175Game Ready* Back Wrap120008555590500-042026-07-31
00812120005182Game Ready* C-T Spine Wrap, Large120008556590502-042026-07-31
00812120005199Game Ready* Hip/Groin Wrap, Right120008557590602-042026-07-31
00812120005205Game Ready* Hip/Groin Wrap, Left120008558590604-042026-07-31
00812120005212Game Ready* Hand/Wrist Wrap120008559590811-042026-07-31
00812120005229Game Ready* Flexed Elbow Wrap120008560590903-042026-07-31
00812120005236Game Ready* Half Leg Boot Wrap120008561590906-042026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, Large120008562590922-042026-07-31
00812120005250Game Ready* Straight Knee Sleeve120009290510100-042026-07-31
00812120005267Game Ready* Articulated Knee Sleeve120009291510160-042026-07-31
00812120005274Game Ready* Straight Elbow Sleeve120009292510200-042026-07-31
00812120005281Game Ready* Ankle Sleeve, Large120009293510330-042026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010778616Amron Oxygen Treatment HoodAmron International, Inc.FOG2024-12-30
00850052737009Sea-Long Medical HoodSea-Long Medical Systems LLCFOG2024-11-21
00860010778609Amron Oxygen Treatment HoodAmron International, Inc.FOG2023-08-10
B366U1VNI1001ECLERIS NIV HELMETEclerisFOG2022-06-30
H67103001DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103011DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103021DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103051DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H6710305W1DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103081DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103131DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103141DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
00350770928081Bite BlockAvanos Medical, Inc.FOG2020-02-05