FDA UDI
In Commercial Distribution
🇺🇸 United States
Trachstay
DI: 00850008733185
·
Model: 11270
·
B&B Medical Technologies
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trachstay
- Primary DI
- 00850008733185
- Version / Model
- 11270
- Catalog Number
- 11270
- Company Name
- B&B Medical Technologies
- Labeler DUNS
- 829743579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-24
- Public Version
- 1
- Public Version Date
- 2020-04-01
- Public Version Status
- New
- Public Device Record Key
- f07fc093-b7ad-47c1-b9be-00ee86743ab3
Device Description
Tracheostomy Tube Anti-Disconnect Device, 50 Units
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | Anesthesiology | 868.5770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63438 | Tracheostomy tube neck holder, single-use | A non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850008733185 | GS1 |