FDA UDI
In Commercial Distribution
🇺🇸 United States
Dale 244 Blue
DI: 00817612020780
·
Model: 244
·
DALE MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Dale 244 Blue
- Primary DI
- 00817612020780
- Version / Model
- 244
- Catalog Number
- 244
- Company Name
- DALE MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 001061233
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-14
- Public Version
- 1
- Public Version Date
- 2019-05-22
- Public Version Status
- New
- Public Device Record Key
- 0e6354ac-a667-43ea-9a82-c6a2fed51b71
Device Description
Dale Bariatric Tracheostomy Tube Holder, 1.5" wide, fits up to 28" neck.
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
- 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 |
|---|---|---|---|---|
| 35752 | Tracheostomy tube neck holder, reusable | A 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817612020797 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00817612020780 | GS1 | ||||
| Previous | H84102441 | HIBCC |