Pediatric Stylet
Basic Information
- Brand Name
- Pediatric Stylet
- Primary DI
- 00859290006359
- Version / Model
- 90201
- Catalog Number
- 90201
- Company Name
- TRUER MEDICAL, INC.
- Labeler DUNS
- 003530786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-30
- Public Version
- 2
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- 59c03680-6d14-4158-ac5e-472d83baed4b
Device Description
The Truer Medical disposable Intubation Stylet is the most adaptable, cost-effective stylet available on the market. Each stylet contains malleable wire encased in a specially designed PVC sheath which allows the Truer Medical Stylet to be used in a wide range of Endotracheal Tube (ETT) sizes while still maintaining the shape you require. With just two stylet sizes in your inventory, all ETT sizes are covered, simplifying inventory control and ordering. A unidirectional end cap doesn’t permit the stylet to advance forward during the intubation process, significantly lowering the risk of unnecessary trauma to the patient. Simply install the stylet into the ETT and engage the unidirectional end cap onto the 15mm ETT connector. Draw the frosted PVC coated wire back to the desired location, shape the ETT, and you are ready to intubate. This assures a procedure that is fast, efficient, and—most importantly—safe.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSR | Stylet, Tracheal Tube | Anesthesiology | 868.5790 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37469 | Artificial airway stylet, single-use | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10859290006356 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 00859290006359 | GS1 | ||||
| Package | 20859290006353 | GS1 | Carton | 25 | In Commercial Distribution | |
| Package | 30859290006350 | GS1 | Carton | 5 | In Commercial Distribution | |
| Package | 40859290006357 | GS1 | Carton | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 7146289785
- [email protected]