FDA UDI
In Commercial Distribution
🇺🇸 United States
TIO™
DI: 10884450122775
·
Model: 10884450122775
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- TIO™
- Primary DI
- 10884450122775
- Version / Model
- 10884450122775
- Catalog Number
- TIO60-100
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-02-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 005ebfa3-2944-4004-b7e8-7832ac605fd8
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
- No
- 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 |
|---|---|---|---|---|
| MNK | Endoscopic bite block | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47162 | Endoscopic bite block, oxygenating | A dual-purpose device inserted into a patient's mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient's natural tendency to bite down on the instrument, and that simultaneously supports an oxygen (O2) line to provide the patient with an uninterrupted flow of O2 during and after endoscopy. The device also protects the tongue and teeth of the patient during endoscopy and may include a gas sample line that enables monitoring of the expired carbon dioxide (CO2) during the procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884450122772 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 10884450122775 | GS1 | ||||
| Unit of Use | 00884450122778 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Blade Length-100 mm |