FDA UDI
In Commercial Distribution
🇺🇸 United States
Trach O-Life
DI: 00850108006899
·
Model: RTG-04017
·
CUTTING EDGE HC BRANDS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Trach O-Life
- Primary DI
- 00850108006899
- Version / Model
- RTG-04017
- Catalog Number
- RTG-04017
- Company Name
- CUTTING EDGE HC BRANDS LLC
- Labeler DUNS
- 080216804
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-25
- Public Version
- 2
- Public Version Date
- 2020-05-11
- Public Version Status
- Update
- Public Device Record Key
- c432e2c0-d3b6-4269-9bdb-9f298c5e0fa0
Device Description
Pediatric Tracheostomy Mask, 22mm Swivel Tubing Connector & One Side Snap. The tracheostomy mask is used to administer aerosol or oxygen into tracheostomy of a surgical patient. It is intended for channeling gases for the purpose of administration of oxygen to patient. It is used to connect to an active medical device.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYG | Mask, Oxygen | Anesthesiology | 868.5580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35179 | Tracheostomy mask, aerosol | A device designed to deliver air, oxygen, or a mixture of the two gases with aerosolized water particles to a patient who has a tracheostomy airway. It is typically connected to an oxygen source and nebulizer with wide bore tubing and is constructed of plastic. The device can be used over a tracheostomy tube or a stoma and is secured with a strap. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850108006896 | GS1 | Carton | 50 | In Commercial Distribution | |
| Primary | 00850108006899 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 22mm Tubing Connector |