FDA.report

TOAD™

Primary DI
10850027065950
Brand
TOAD™
Company
Wm & Dg, Inc.
Model
DP10
Device description
DP10 Medical Display for Video Laryngoscope
Published
2024-08-07
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
false

Related Records

Product Codes

CodeName
CCWLaryngoscope, Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850027065950PackageGS15In Commercial Distribution
00850027065953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002706595010850027065950
00850027065953008500270659538500270659530850027065953

GMDN Terms

TermDefinition
Channelled video intubation laryngoscopeA hand-held device intended to enable clear view of the trachea via video imaging to facilitate positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation, passing the ET tube through an integrated ET tube channel guide without use of a stylet for positioning. It typically consists of a body with an ET tube channel, an anatomically-shaped blade, and integrated electronic illumination and a video camera at the distal end; images are transmitted to an off-the-shelf device (e.g., tablet, smartphone, computer). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
117870208
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
10850027066018TOAD™S-DVL2024-10-23
00850027060026TOADS-VLB2024-08-07
10850027061006TOAD™S-VW2024-08-07
10850027062119TOAD™S-VL-012024-08-07
10850027063017Big Mouth™ Oral Airway with Balloon OA4100OA41002023-02-23
00850027063027LIVVE™ Size 3.5LB1535LB15352023-02-23
00850027063034LIVVE™ Size 4.5LB1545LB15452023-02-23
10850027063048Bougie Stylet B62400B624002023-02-23

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