FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambu® SureSight TM Stylet; large
DI: 04250105630459
·
Model: 321900030
·
VBM Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Ambu® SureSight TM Stylet; large
- Primary DI
- 04250105630459
- Version / Model
- 321900030
- Company Name
- VBM Medizintechnik GmbH
- Labeler DUNS
- 324869601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-02
- Public Version
- 2
- Public Version Date
- 2025-07-15
- Public Version Status
- Update
- Public Device Record Key
- d4083aba-8385-4675-a3ca-d40ef9b6ba44
Device Description
for tracheal tube I.D greater or equal 6 mm
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed.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 | 14250105630456 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04250105630459 | GS1 | ||||
| Package | 24250105630453 | GS1 | 140 | In Commercial Distribution |
Customer Contacts
- Phone
- +49745495960
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight and heat.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry.