Home GUDID 00816472021616
Solus Laryngeal Mask Airway Kit, Size 4
Primary DI 00816472021616
Brand Solus Laryngeal Mask Airway Kit, Size 4
Company Intersurgical Incorporated
Model 8004032
Device description Solus Laryngeal Mask Airway Kit, Size 4
Published 2023-06-13
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816472021616 Package GS1 10 In Commercial Distribution 00816472021609 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816472021616 00816472021616 816472021616 0816472021616 00816472021609 00816472021609 816472021609 0816472021609
GMDN Terms# Term, Definition table Term Definition Laryngeal mask airway, single-use A curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. This is a single-use device.
Regulatory Flags# DUNS number 785952607 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false 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 DI, Brand, Model table Primary DI Brand Model Catalog Published 05030267169870 I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US) 8201030 2026-06-02 05030267169894 I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.0, SMALL PAEDIATRIC, 10-25KG (US) 8202030 2026-06-02 05030267169917 I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US) 8203030 2026-06-02 05030267169931 I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US) 8204030 2026-06-02 05030267169955 I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US) 8205030 2026-06-02 05030267169979 I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.5, INFANT, 5-12KG (US) 8215030 2026-06-02 05030267169993 I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.5, LARGE PAEDIATRIC, 25-35KG (US) 8225030 2026-06-02 05030267170012 I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US) 8903030 2026-06-02 05030267170036 I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US) 8904030 2026-06-02 05030267170050 I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US) 8905030 2026-06-02 05030267089123 FIXED ELBOW, 15M - 22M/15F - STERILE 1997000S 2026-04-28 05030267169542 SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER 1143035 2026-04-21 05030267169573 SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH TUBE, 2.1M USA ONLY 1141035 2026-04-21 05030267169597 SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER 1143038 2026-04-21 05030267169634 SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO MONITORING LINE AND TUBE 1142035 2026-04-21 05030267056057 Y-PIECE 22M, 22M, 22M/15F 1900000 2021-10-12 05030267056095 Y-PIECE 22M, 22M, 22M/15F WITH PORTS 1901000 2021-10-12 05030267056118 Y-PIECE 15M, 15M, 15F 1902000 2021-10-12 05030267056132 Y-PIECE 15M, 15M, 22M/15F + 7.6MM PORTS, PAEDIATRIC 1903000 2021-10-12 05030267056347 PARALLEL Y-PIECE, 22MM 1926000 2021-10-12