FDA.report

Portex

Primary DI
35019315055908
Brand
Portex
Company
Smiths Medical ASD, Inc.
Model
100/120/300
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BSRSTYLET, TRACHEAL TUBE

Product Code Classifications

CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
35019315055908PackageGS110In Commercial Distribution
55019315055902PackageGS110In Commercial Distribution
15019315055904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3501931505590835019315055908
5501931505590255019315055902
1501931505590415019315055904

GMDN Terms

TermDefinition
Artificial airway stylet, single-useA 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 It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed.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

Regulatory Flags

DUNS number
082005361
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10887709142326BivonaFT24LN40NSE166N2024-12-19
10887709142333BivonaSU24LN40NSB167N2024-12-19
10887709142340BivonaHF24LS90NSB174N2024-12-19
10887709142357BivonaFT24LN55NGF172N2024-12-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20889483033309SunMedSUNMED, LLCBSR2026-02-18
20889483033316SunMedSUNMED, LLCBSR2026-02-18
20889483033323SunMedSUNMED, LLCBSR2026-02-18
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
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
10860004198861Stylet – Tracheal Tube/ Bougie CatheterGMMI SDN. BHD.BSR2025-05-23
05030267167678UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANTIntersurgical IncorporatedBSR2025-03-14
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16936881166683Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166690Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166706Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
06936881166716Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166720Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773414Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773438Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773445Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773452Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773483Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
06970283489394UE Intubation StyletZhejiang UE Medical CorpBSR2024-12-17
06970283489424UE Intubation StyletZhejiang UE Medical CorpBSR2024-12-17
00850059297070Runnels Steerable Introducer™ #2.5 Oral/NasalThrough The Cords, LLCBSR2024-10-23
00850059297018Runnels Steerable Introducer™ #5 NasalThrough The Cords, LLCBSR2024-10-22
00850059297049Runnels Steerable Introducer™ #2 Oral/NasalThrough The Cords, LLCBSR2024-10-22
00850059297100Runnels Steerable Introducer™ #3 Oral/NasalThrough The Cords, LLCBSR2024-10-22
00850059297131Runnels Steerable Introducer™ DLT (35F/37F)Through The Cords, LLCBSR2024-10-22