FDA.reportPublic FDA data

IntuBrite Sterile

Primary DI
00607411967993
Brand
IntuBrite Sterile
Company
SALTER LABS
Model
S01-1033.C.2017.C
Catalog number
S01-1033.C.2017.C
Device description
MILLER 3/STUBBY SINGLE USE DISPOSABLE LARYNGOSCOPE SYSTEM-STERILE
Published
2018-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10607411967990PackageGS15In Commercial Distribution
00607411967993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741196799010607411967990
00607411967993006074119679936074119679930607411967993

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.

Contacts#

Phone, Email table
PhoneEmail
+8004210024customercare@salterlabs.com

Regulatory Flags#

DUNS number
022721133
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411919008Salter Labs® Adult Comfort Face Tent131032026-06-09
00607411919053Salter Labs® Oxygen Mask131242026-06-09
00607411919060Salter Labs® Oxygen Mask131252026-06-09
00607411919084MedTronic Cannula133012026-06-09
00607411919107Salter Labs® Nasal Cannula133072026-06-09
00607411919138Salter Labs® Nasal Cannula133102026-06-09
00607411919206MedTronic ETCo2 Cannula133402026-06-09
00607411919220Salter Labs® Oxygen Tubing134002026-06-09
00607411919237Salter Labs® Oxygen Tubing134042026-06-09
00607411919244Salter Labs® Oxygen Tubing134072026-06-09
00607411919251Salter Labs® Oxygen Tubing (MedTronic)134082026-06-09
00607411919299MedTronic NebuTech135002026-06-09
00607411919329Salter Labs® NebuTech®135062026-06-09
00607411919350Salter Labs® Full Kit Nebulizer139512026-06-09
00607411000737N/A8900-148900-142016-09-24
00607411006814N/ASO-1343SO-13432016-09-24
00607411009297N/ASO-1666-0SO-1666-02016-09-24
00607411102738N/A7914-147914-142016-12-22
00607411300059N/ASO-388-0SO-388-02016-09-24
00607411700002N/A7100-07100-02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055251339Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251346Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251353Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251360Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251377Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251384Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251391Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251414Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251421Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251445Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251452Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251469Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251476Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251483Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251490Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251506Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257744Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257768Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257782Surgical DesignSurgical Design, Inc.CCW2026-06-09
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