FDA.reportPublic FDA data

Intubating Stylet, Size 14FR, OD 4.7mm

Primary DI
06923310902892
Brand
Intubating Stylet, Size 14FR, OD 4.7mm
Company
Hangzhou Formed Medical Devices Co.Ltd.
Model
PA180114
Catalog number
PA180114
Published
2022-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
06923310902892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923310902892069233109028926923310902892

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 It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed.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
560463769
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923310901291Naso-Pharyngeal Airway, Size 3.0PA190230PA1902302022-12-13
06923310901307Naso-Pharyngeal Airway, Size 3.5PA190235PA1902352022-12-13
06923310901314Naso-Pharyngeal Airway, Size 4.0PA190240PA1902402022-12-13
06923310901321Naso-Pharyngeal Airway, Size 4.5PA190245PA1902452022-12-13
06923310901338Naso-Pharyngeal Airway, Size 5.0PA190250PA1902502022-12-13
06923310901345Naso-Pharyngeal Airway, Size 5.5PA190255PA1902552022-12-13
06923310901352Naso-Pharyngeal Airway, Size 6.0PA190260PA1902602022-12-13
06923310901369Naso-Pharyngeal Airway, Size 6.5PA190265PA1902652022-12-13
06923310901376Naso-Pharyngeal Airway, Size 7.0PA190270PA1902702022-12-13
06923310901383Naso-Pharyngeal Airway, Size 7.5PA190275PA1902752022-12-13
06923310901390Naso-Pharyngeal Airway, Size 8.0PA190280PA1902802022-12-13
06923310901406Naso-Pharyngeal Airway, Size 8.5PA190285PA1902852022-12-13
06923310901413Naso-Pharyngeal Airway, Size 9.0PA190290PA1902902022-12-13
06923310902908Guedel Airway, Size 4.0PA040104PA0401042022-12-13
06923310902915Guedel Airway, Size 5.0PA040105PA0401052022-12-13
06923310902922Guedel Airway, Size 6.0PA040106PA0401062022-12-13
06923310902939Guedel Airway, Size 7.0PA040107PA0401072022-12-13
06923310902946Guedel Airway, Size 8.0PA040108PA0401082022-12-13
06923310902953Guedel Airway, Size 9.0PA040109PA0401092022-12-13
06923310902960Guedel Airway, Size 10.0PA040110PA0401102022-12-13

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