FDA UDI
In Commercial Distribution
🇺🇸 United States
Dr Zee
DI: 00850043061045
·
Model: 8005
·
Resp Devices LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dr Zee
- Primary DI
- 00850043061045
- Version / Model
- 8005
- Catalog Number
- 8005
- Company Name
- Resp Devices LLC
- Labeler DUNS
- 104305239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-01
- Public Version
- 1
- Public Version Date
- 2022-11-09
- Public Version Status
- New
- Public Device Record Key
- 324bf29c-0bcb-4dbc-87b1-1bcd7c588755
Device Description
Tracheostomy Tube Holders. One-Piece Foam Collar with Hook and Loop Closure, Medium, 50/cs
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10850043061042 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00850043061045 | GS1 |
Customer Contacts
- Phone
- 917-299-1512
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Medium. Neck cirumference 9-14"/23-35cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight.