FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ProTrach® DualCare™ Set 15
DI: 07331791008191
·
Model: 7741
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ProTrach® DualCare™ Set 15
- Primary DI
- 07331791008191
- Version / Model
- 7741
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 6
- Public Version Date
- 2023-06-05
- Public Version Status
- Update
- Public Device Record Key
- ceaca718-fce8-46b0-8e95-2dcd7cb9363b
- Distribution End Date
- 2023-06-05
Device Description
ProTrach DualCare is a combined speaking valve and heat & moisture exchanger (HME) intended for tracheostomized patients using a tracheostomy tube. In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air. By turning the lid of the speaking valve into speaking mode air is re-directed to enable speech.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36071 | Tracheostomy tube speech valve | A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07331791008191 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151404 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 15 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight.