FDA.reportPublic FDA data

SunMed

Primary DI
10889483040218
Brand
SunMed
Company
SUNMED, LLC
Model
5-0236-31
Catalog number
5-0236-31
Device description
F/o Greenline S/s Handle Stub
Published
2023-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10889483040218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948304021810889483040218

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length109Millimeter
Length129Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
DM exempt
true
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
10889483222157Ambu900-000-601900-000-6012025-12-19
10889483222164Ambu900-000-602900-000-6022025-12-19
10889483222188Ambu900-000-604900-000-6042025-12-19
10889483222195Ambu900-000-605900-000-6052025-12-19
10889483222201Ambu900-000-606900-000-6062025-12-19
10889483222225Ambu900-000-609900-000-6092025-12-19
10889483222232Ambu900-000-611900-000-6112025-12-19
10889483231494Ambu900-000-614900-000-6142025-12-19
10889483231524Ambu900-000-617900-000-6172025-12-19
10889483231531Ambu900-000-618900-000-6182025-12-19
10889483231586Ambu900-000-624900-000-6242025-12-19
10889483231616Ambu900-000-628900-000-6282025-12-19
10889483565339BALLARD™97012970122025-12-01
10889483565346BALLARD™97014970142025-12-01
10889483565360BALLARD™97020970202025-12-01
10889483565377BALLARD™97021970212025-12-01
10889483155912SunMed4-0050-10M4-0050-10M2023-07-18
10889483225448Septal-H™CP-5410CP-54102025-12-15
10889483225455Septal-H™CP-5500CP-55002025-12-15
10889483230244AirLife™TC-1022TC-10222025-12-15

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