FDA UDI
In Commercial Distribution
🇺🇸 United States
X-Changer
DI: 04250105629712
·
Model: 33-41-800-1
·
VBM Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- X-Changer
- Primary DI
- 04250105629712
- Version / Model
- 33-41-800-1
- Company Name
- VBM Medizintechnik GmbH
- Labeler DUNS
- 324869601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-14
- Public Version
- 1
- Public Version Date
- 2023-08-22
- Public Version Status
- New
- Public Device Record Key
- 5d97826a-2598-460b-b968-7cf7d6018d89
Device Description
14 Fr; Length: 80 cm; O2-15 mm O.D.; O2
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 Safe
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 41829 | Endotracheal tube introducer, single-use | A device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14250105629719 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 04250105629712 | GS1 |
Customer Contacts
- Phone
- +49745495960
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 80 | Centimeter | |
| Outer Diameter | 15 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunhight and heat.