FDA UDI
In Commercial Distribution
🇺🇸 United States
RUSCH
DI: 54026704646703
·
Model: IPN029546
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- RUSCH
- Primary DI
- 54026704646703
- Version / Model
- IPN029546
- Catalog Number
- 120900040
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-30
- Public Version
- 1
- Public Version Date
- 2025-02-07
- Public Version Status
- New
- Public Device Record Key
- f257ee7d-1ccf-4848-b1a5-d1cb92728690
Device Description
QUICKTRACH Emergency Cricothyrotomy DeviceSize 4.0 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
- No
- 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 |
|---|---|---|---|---|
| BTO | Tube, tracheostomy (w/wo connector) | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34975 | Cricothyrotome, reusable | A 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 64026704646700 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 54026704646703 | GS1 | ||||
| Package | 44026704646706 | GS1 | Carton | 68 | In Commercial Distribution | |
| Previous | 14026704646705 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K874742 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 4 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Special Storage Condition, Specify: Keep dry, Keep away from sunlight and heat