FDA.reportPublic FDA data

ProVu Video Stylet Reusable 2m Amplifier Cable

Primary DI
05055788782506
Brand
ProVu Video Stylet Reusable 2m Amplifier Cable
Company
FLEXICARE MEDICAL LIMITED
Model
038-990-012U
Published
2020-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BSRStylet, Tracheal Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055788782506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788782506050557887825065055788782506

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 It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed.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
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055788767640Leg Bag Holder Extra Large00-0038U2020-03-25
05055788767671Leg Bag Holder Large00-0037U2020-03-25
05055788767701Leg Bag Holder Medium00-0036U2020-03-25
05055788767732Leg Bag Holder Small00-0035U2020-03-25
05055788787044Flexicare040-11-0000U2026-03-31
05055788787068Flexicare040-12-0130U2026-03-31
05055788787082Flexicare040-12-0140U2026-03-31
05055788787105Flexicare040-12-2130U2026-03-31
05055788787129Flexicare040-12-2135U2026-03-31
05055788787143Flexicare040-12-2140U2026-03-31
05055788791317Flexicare030-620/1U2024-03-13
05055931101963Maxineb Duo Filter Pad032-10-021U2020-03-27
05055931101970Maxineb Duo032-10-031U2020-03-27
05055931101994Maxineb Duo Nebulizer + Mouthpiece032-10-033U2020-03-27
05055931102014Maxineb Duo Nebulizer + Mouthpiece And Filter032-10-034U2020-03-27
05055931102038Maxineb Duo Filter032-10-035U2020-03-27
05055931102052Maxineb Duo Filter Master Case032-10-036U2020-03-27
05055931102076Maxineb Duo Nebulizer And Tubing032-10-037U2020-03-27
05055931102090Maxineb Duo Nebulizer + Mouthpiece And Tubing032-10-038U2020-03-27
05055931102113Maxineb Duo Nebulizer + Mouthpiece, Tubing And Filter032-10-039U2020-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851232007165RTech REUSABLE INTUBATION STYLET D R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007172RTech STERILE DISPOSABLE INTUBATION STYLETD R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007189RTech NON-STERILE DISPOSABLE INTUBATION STYLETD R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007196J-WAND ADVANTAGE INTUBATION STYLET, NON-STERILED R BURTON HEALTHCARE, LLCBSR2026-04-28
10889483033302SunMedSUNMED, LLCBSR2026-02-18
10889483033319SunMedSUNMED, LLCBSR2026-02-18
10889483033326SunMedSUNMED, LLCBSR2026-02-18
20889483033309SunMedSUNMED, LLCBSR2026-02-18
20889483033316SunMedSUNMED, LLCBSR2026-02-18
20889483033323SunMedSUNMED, LLCBSR2026-02-18
00848530094676AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
00848530094683AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
00848530094690AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
00848530094706AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094673AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094680AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094697AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094703AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
04250105630442Ambu® SureSight TM Stylet; mediumVBM Medizintechnik GmbHBSR2025-07-02
04250105630459Ambu® SureSight TM Stylet; largeVBM Medizintechnik GmbHBSR2025-07-02
04250105630435Ambu® SureSight TM Stylet; smallVBM Medizintechnik GmbHBSR2025-07-02
14250105630449Ambu® SureSight TM Stylet; mediumVBM Medizintechnik GmbHBSR2025-07-02
14250105630456Ambu® SureSight TM Stylet; largeVBM Medizintechnik GmbHBSR2025-07-02
05055788776246ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776260ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776284ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776307ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
00860004198864Stylet – Tracheal Tube/ Bougie CatheterGMMI SDN. BHD.BSR2025-05-23
10860004198861Stylet – Tracheal Tube/ Bougie CatheterGMMI SDN. BHD.BSR2025-05-23
05030267108763UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANTIntersurgical IncorporatedBSR2025-03-14