FDA.reportPublic FDA data

LIVVE™ Size 4.5

Primary DI
00850027063034
Brand
LIVVE™ Size 4.5
Company
Wm & Dg, Inc.
Model
LB1545
Catalog number
LB1545
Device description
The LIVVE™ (Laryngeal, Intubating, Visualizing, Ventilating, and Extubating Device) is a single-use, non-sterile, 2-lumen channel device with a cushioned cuff to ensure a semi-closed ventilation system is maintained during ventilation and oral intubation. Adult size 4.5: > 90 kg (198 lbs)
Published
2023-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850027063031PackageGS115In Commercial Distribution
20850027063038PackageGS14In Commercial Distribution
00850027063034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002706303110850027063031
2085002706303820850027063038
00850027063034008500270630348500270630340850027063034

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mask airway, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117870208
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
00850027066011TOAD™S-DVL2024-10-23
10850027066018TOAD™S-DVL2024-10-23
00850027061009TOAD™S-VW2024-08-07
00850027062112TOAD™S-VL-012024-08-07
00850027065953TOAD™DP102024-08-07
00850027060026TOADS-VLB2024-08-07
10850027061006TOAD™S-VW2024-08-07
10850027062119TOAD™S-VL-012024-08-07
10850027065950TOAD™DP102024-08-07
00850027063010Big Mouth™ Oral Airway with Balloon OA4100OA41002023-02-23
00850027063041Bougie Stylet B62400B624002023-02-23
10850027063017Big Mouth™ Oral Airway with Balloon OA4100OA41002023-02-23
00850027063027LIVVE™ Size 3.5LB1535LB15352023-02-23
10850027063048Bougie Stylet B62400B624002023-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06920687314037INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
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06920687314051INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314068INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314075INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314082INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314099INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314105INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314112INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
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06920687314136INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314143INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314150INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
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06920687314198INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314204INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314211INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
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06920687314235INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314242INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
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06920687314303INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314310INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314327INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314334INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06946430427632CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2026-08-08
05060112310058LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03