FDA.reportPublic FDA data

RhinoGuard™

Primary DI
10860622000317
Brand
RhinoGuard™
Company
DAVIS MEDICAL LLC
Model
Large
Catalog number
02.26.97
Device description
Nasal endotracheal tube introducer/dilator for 5.0 to 8.0 nasal endotracheal tubes
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860622000317PackageGS110Not in Commercial Distribution
00860622000310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086062200031710860622000317
00860622000310008606220003108606220003100860622000310

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube introducer, single-useA device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
540-492-0453davismedical@lumos.net

Regulatory Flags#

DUNS number
080343839
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00860622000303RhinoGuard™Small04.02.032016-09-23
00860622000310RhinoGuard™Large02.26.972016-09-23
10860622000300RhinoGuard™Small04.02.032016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344104659MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104666MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104673MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104680MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104697MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104703MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104710MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104727MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104734MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104741MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104758MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104765MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104772MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104789MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104796MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104802MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104819MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104826MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104833MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104840MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104857MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104864MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104871MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104888MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104895MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104901MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10190752147799Vital Signs™AIRLIFEBTR2021-06-14
10190752147751Vital Signs™AIRLIFEBTR2021-04-09
10190752147768Vital Signs™AIRLIFEBTR2021-04-09
10190752147775Vital Signs™AIRLIFEBTR2021-04-09