FDA.reportPublic FDA data

ProVu Single Use Video Stylet with ET Tube Size 6.5

Primary DI
05055788782513
Brand
ProVu Single Use Video Stylet with ET Tube Size 6.5
Company
FLEXICARE MEDICAL LIMITED
Model
038-990-065U
Published
2020-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055788782513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788782513050557887825135055788782513

GMDN Terms#

Term, Definition table
TermDefinition
Artificial airway stylet, single-useA sterile, long, stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
504406273
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
05055788776246ProVu Video Stylet038-995-065U038-995-065U2025-05-30
05055788776260ProVu Video Stylet038-995-070U038-995-070U2025-05-30
05055788776284ProVu Video Stylet038-995-075U038-995-075U2025-05-30
05055788776307ProVu Video Stylet038-995-080U038-995-080U2025-05-30
05055788721499Flexicare040-836U2024-11-21
05055788721550Flexicare040-835U2024-11-21
05055788721802Flexicare040-831U2024-11-21
15055788722462BriteBlade Pro Evo Single-Use Fiber Optic Miller 4040-764U2024-08-07
15055788722486BriteBlade Pro Evo Single-Use Fiber Optic Miller 3040-763U2024-08-07
15055788722509BriteBlade Pro Evo Single-Use Fiber Optic Miller 2040-762U2024-08-07
15055788722523BriteBlade Pro Evo Single-Use Fiber Optic Miller 1040-761U2024-08-07
15055788722561BriteBlade Pro Evo Single-Use Fiber Optic Mac 4040-754U2024-08-07
15055788722585BriteBlade Pro Evo Single-Use Fiber Optic Mac 2040-753U2024-08-07
15055788722608BriteBlade Pro Evo Single-Use Fiber Optic Mac 1040-752U2024-08-07
15055788722622BriteBlade Pro Evo Single-Use Fiber Optic Mac 1040-751U2024-08-07
05055931127888Flexicare032-10-180LU2024-07-17
05055931127895Flexicare032-10-181LU2024-07-17
05055931127901Flexicare032-10-182LU2024-07-17
05055931127918Flexicare010-762LU2024-07-17
05055931104162ProVu040-08-0420U2024-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704941043SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941057SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941064SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941074SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941081SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941095SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941101SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941118SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941128SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941132SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941149SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
44026704617195TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
44026704617201TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
34026704617211TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
34026704617235TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
44026704617911HUDSON RCITELEFLEX INCORPORATEDBTR2025-11-20
34026704930976SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704930983SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704930990SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931006SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931013SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931027SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931037SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931041SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931058SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931065SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
05055788776246ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776260ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776284ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776307ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30