FDA.reportPublic FDA data

NOVALITE

Primary DI
10817499020849
Brand
NOVALITE
Company
NOVAMED-USA INC.
Model
16-400-FOMD-OX-1
Device description
SINGLE USE FO HYBRID SS WITH ACRYLIC FO BUNDLE OXFORD1 LARYNGOSCOPE BLADE
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817499020849PackageGS110In Commercial Distribution
00817499020842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081749902084910817499020849
00817499020842008174990208428174990208420817499020842

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, single-useThe segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
914-789-2100info@novamed-usa.com

Regulatory Flags#

DUNS number
831531426
Device count
1
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
00817499020859NOVALITE18-600SMH2023-06-28
00817499020866NOVALITE18-600SPH2023-06-28
00817499020873NOVALITE18-600SSH2023-06-28
00817499020453NOVATEMP11-CA-400-122023-06-28
00817499020460NOVATEMP11-CA-400-202023-06-28
00817499020477NOVATEMP11-CA-401-122023-06-28
00817499020484NOVATEMP11-CA-401-202023-06-28
00817499020491NOVATEMP11-CA-402-102023-06-28
00817499020507NOVATEMP11-CA-402-122023-06-28
00817499020514NOVATEMP11-CA-402-202023-06-28
00817499020521NOVATEMP11-CA-403-122023-06-28
00817499020538NOVATEMP11-CA-404-122023-06-28
00817499020545NOVATEMP11-CA-404-202023-06-28
00817499020552NOVATEMP11-CA-405-122023-06-28
00817499020569NOVATEMP11-CA-407-042023-06-28
00817499020576NOVATEMP11-CA-407-122023-06-28
10817499020856NOVALITE18-600SMH2023-06-28
10817499020863NOVALITE18-600SPH2023-06-28
10817499020870NOVALITE18-600SSH2023-06-28
00817499020880NOVALITE14-600S-012023-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00879123009340GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
00879123009357GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
08436031030112AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030211AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030310AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030419AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030518AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030617AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033908AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033922AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035018AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035117AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035216AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035902AirtraqPRODOL MEDITEC, SACCW2023-08-01
G14140464270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-05
G1414046400Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464290Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G1414046430Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464370Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464380Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G141404643850Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464390Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G1414046440Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464470Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464480Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464490Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466170Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03