FDA.reportPublic FDA data

SunMed

Primary DI
10889483008706
Brand
SunMed
Company
SUNMED, LLC
Model
5-5851-03
Catalog number
5-5851-03
Device description
MACINTOSH ENG BLADE W/CONV LED SZ 3
Published
2023-08-01
Public version status
New
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
10889483008706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948300870610889483008706

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, reusableThe 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length130Millimeter

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
10889483479407Atellica® VTR Syringes115613422023-06-30
10889483479414Atellica® VTR Syringes115613432023-06-30
10889483479469Atellica® VTR Syringes115613482023-06-30
10889483054321AirLife™048004802025-12-18
10889483054338AirLife™079507952025-12-19
10889483229422AirLife™048504852025-12-19
10889483564288BALLARD™22103-522103-52025-11-20
10889483564394BALLARD™22113-522113-52025-11-21
10889483564608BALLARD™227101322710132025-11-24
10889483564646BALLARD™22712183227121832025-11-24
10889483564806BALLARD™2271603-52271603-52025-11-21
10889483564813BALLARD™22716036-522716036-52025-11-21
10889483564905BALLARD™227166-5227166-52025-11-21
10889483564936BALLARD™2276-52276-52025-11-21
10889483567005BALLARD™2271652271652025-11-24
10889483623411BALLARD™22056-522056-52025-11-20
10889483623541BALLARD™2271516-52271516-52025-11-21
10889483562611BALLARD™227-5227-52025-11-21
10889483564370BALLARD™22108-522108-52025-11-21
10889483564424BALLARD™2255-52255-52025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971355350147BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350154BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350161BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350178BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350512BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350529BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350888BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
00190776427580MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427597MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427603MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
14026704760548PILLINGTELEFLEX INCORPORATEDCCW2026-07-31
25056094503100PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503117PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503124PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503131PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503148PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503155PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503162PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503179PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503186PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503193PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503209PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503216PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503223PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503230PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503254PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503261PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31