FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RÜSCH
DI: 04250105621709
·
Model: 120900040
·
VBM Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RÜSCH
- Primary DI
- 04250105621709
- Version / Model
- 120900040
- Company Name
- VBM Medizintechnik GmbH
- Labeler DUNS
- 324869601
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-01-17
- Public Version
- 4
- Public Version Date
- 2019-07-17
- Public Version Status
- Update
- Public Device Record Key
- f45f4e81-9119-4bab-9654-eb7c3f33df90
- Distribution End Date
- 2019-07-16
Device Description
RÜSCH QUICKTRACH
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11052 | Cricothyrotome, single-use | A sterile, hand-held, manual surgical instrument intended to be used to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage of the upper airway tract, and prior to tracheotomy. It is made of high-grade stainless steel and plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250105621709 | GS1 |
Customer Contacts
- Phone
- +49745495960
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K874742 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry, Keep away from sunlight and heat