FDA.reportPublic FDA data

IntuBrite

Primary DI
00607411964459
Brand
IntuBrite
Company
SALTER LABS
Model
6016.C
Catalog number
6016.C
Device description
PEDIATRIC SINGLE USE DISPOSABLE FIBER OPTIC LARYNGOSCOPE HANDLE
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
10607411964456PackageGS120In Commercial Distribution
00607411964459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741196445610607411964456
00607411964459006074119644596074119644590607411964459

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope handle, reusableThe hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. This is a reusable 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
00607411890178N/A891289122016-09-24
00607411890185N/A891389132016-09-24
00607411890246N/A892389232016-09-24
00607411000881N/A5006-15006-12016-09-24
00607411917332Salter LabsOTC-101-7 (QTY 5)OTC-101-7 (QTY 5)2026-10-07
00607411917363Salter LabsOTC-102-4 (QTY 5)OTC-102-4 (QTY 5)2026-10-07
00607411917394Salter LabsOTC-102-7 (QTY 5)OTC-102-7 (QTY 5)2026-10-07
00607411000966AirLife7001-07001-02016-11-30
00607411001130AirLife1220-01220-02016-11-30
00607411001215AirLife1225-01225-02016-11-30
00607411888922N/AM5120-0M5120-02016-09-24
00607411917615n/aOTC-203-25 (QTY1)OTC-203-25 (QTY1)2016-11-30
00607411917646n/aOTC-203-50 (QTY1)OTC-203-50 (QTY1)2016-11-30
00607411918346Salter AIRE EliteSO-1774BESO-1774BE2016-09-24
00607411400711N/ASO-431SO-4312016-09-24
10607411920117N/AM123138-0M123138-02016-09-24
00607411000409N/ASO-1394SO-13942016-09-24
00607411000461N/ASO-1392-0SO-1392-02016-09-24
00607411000478N/ASO-1393SO-13932016-09-24
00607411005756N/ASO-1608-0SO-1608-02016-09-24

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Primary DI, Brand, Company table
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25056094505425PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505456PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
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25056094505470PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
00190776434038MillenniumAvalign Technologies, Inc.CCW2026-10-09
00190776434045MillenniumAvalign Technologies, Inc.CCW2026-10-09
00190776434052MillenniumAvalign Technologies, Inc.CCW2026-10-09
06971834830016Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830023Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830030Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830047Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830542Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830559Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830566Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830573Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830580Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30