FDA.reportPublic FDA data

wellead

Primary DI
06944932791879
Brand
wellead
Company
Well Lead Medical Co.,Ltd
Model
10-0048
Device description
Cricothyrotomy kit, Type I, Cuffed, 6.0mm DEHP FREE (Sterile)
Published
2021-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGPCricothyrotomy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGPCricothyrotomy KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16944932791876PackageGS110In Commercial Distribution
26944932791873PackageGS110In Commercial Distribution
06944932791879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694493279187616944932791876
2694493279187326944932791873
06944932791879069449327918796944932791879

GMDN Terms#

Term, Definition table
TermDefinition
Cricothyrotomy kit, single-useA collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device.

Regulatory Flags#

DUNS number
544811862
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925816656057Suction CatheterFN02A0606202026-06-03
06925816673962Wellead Hydrophilic Intermittent Catheter F01L0308302026-04-03
06925816673979Wellead Hydrophilic Intermittent Catheter F01L0310302026-04-03
06925816673986Wellead Hydrophilic Intermittent Catheter F01L0312302026-04-03
06925816673993Wellead Hydrophilic Intermittent Catheter F01L0314302026-04-03
06925816674006Wellead Hydrophilic Intermittent Catheter F01L0316302026-04-03
06925816674013Wellead Hydrophilic Intermittent Catheter F01L0318302026-04-03
06925816674020Wellead Hydrophilic Intermittent Catheter F01L0208202026-04-03
06925816674037Wellead Hydrophilic Intermittent Catheter F01L0210202026-04-03
06925816674044Wellead Hydrophilic Intermittent Catheter F01L0212202026-04-03
06925816674051Wellead Hydrophilic Intermittent Catheter F01L0214202026-04-03
06925816674068Wellead Hydrophilic Intermittent Catheter F01L0216202026-04-03
06925816674075Wellead Hydrophilic Intermittent Catheter F01L0218202026-04-03
06925816674082Wellead Hydrophilic Intermittent Catheter F01L0410302026-04-03
06925816674099Wellead Hydrophilic Intermittent Catheter F01L0412302026-04-03
06925816674105Wellead Hydrophilic Intermittent Catheter F01L0414302026-04-03
06925816674112Wellead Hydrophilic Intermittent Catheter F01L0416302026-04-03
06925816674129Wellead Hydrophilic Intermittent Catheter F01L0418302026-04-03
06925816674136Wellead Hydrophilic Intermittent Catheter F01L0108102026-04-03
06925816674143Wellead Hydrophilic Intermittent Catheter F01L0110102026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842209138586NARNORTH AMERICAN RESCUE, LLCOGP2026-04-22
10198956284685CARDINAL HEALTHCardinal Health 200, LLCOGP2026-01-16
50198956284683CARDINAL HEALTHCardinal Health 200, LLCOGP2026-01-16
00850063404433ForwardSynchronis Medical, LLCOGP2025-12-31
00850063404440ForwardSynchronis Medical, LLCOGP2025-12-31
M689HHECT01040Emergency Cric KitSafeguard US Operating, LLCOGP2025-12-19
10198956257818CARDINAL HEALTHCardinal Health 200, LLCOGP2025-12-11
50198956257816CARDINAL HEALTHCardinal Health 200, LLCOGP2025-12-11
00850070635066Endotracheal KitNar Medical Depot, LLCOGP2025-12-01
00850062467132Universal Stylette Bougie Assisted Cricothyrotomy (USBCR)Altitude Technologies Inc.OGP2025-08-04
00860009615564Endotracheal KitNar Medical Depot, LLCOGP2025-07-21
10198956054233CARDINAL HEALTHCardinal Health 200, LLCOGP2025-05-29
50198956054231CARDINAL HEALTHCardinal Health 200, LLCOGP2025-05-29
00842209135066NARNORTH AMERICAN RESCUE, LLCOGP2025-05-21
00842209133789NARNORTH AMERICAN RESCUE, LLCOGP2024-12-18
00842209130597NARNORTH AMERICAN RESCUE, LLCOGP2024-03-13
00842209130337NARNORTH AMERICAN RESCUE, LLCOGP2024-02-28
00842209130368NARNORTH AMERICAN RESCUE, LLCOGP2024-02-28
00842209129690TACTICAL CricKITNORTH AMERICAN RESCUE, LLCOGP2024-01-17
00842209129249TACTICAL CricKITNORTH AMERICAN RESCUE, LLCOGP2023-11-16
00842209128327NARNORTH AMERICAN RESCUE, LLCOGP2023-08-24
00842209127658NARNORTH AMERICAN RESCUE, LLCOGP2023-06-29
00842209127665NARNORTH AMERICAN RESCUE, LLCOGP2023-06-29
00842209127481NARNORTH AMERICAN RESCUE, LLCOGP2023-06-13
00842209127580NARNORTH AMERICAN RESCUE, LLCOGP2023-06-13
00842209126576NARNORTH AMERICAN RESCUE, LLCOGP2023-03-22
00842209126590NARNORTH AMERICAN RESCUE, LLCOGP2023-03-22
10197106110959CARDINAL HEALTHCardinal Health 200, LLCOGP2023-02-22
50197106110957CARDINAL HEALTHCardinal Health 200, LLCOGP2023-02-22
M689HHSCK01EA020Simplified Cricothyrotomy KitSafeguard US Operating, LLCOGP2022-08-10