FDA UDI
In Commercial Distribution
🇺🇸 United States
Salivary Bypass Tube
DI: 00815347023649
·
Model: SBT-08
·
HOOD, E BENSON LABORATORIES INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Salivary Bypass Tube
- Primary DI
- 00815347023649
- Version / Model
- SBT-08
- Company Name
- HOOD, E BENSON LABORATORIES INC
- Labeler DUNS
- 076603380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-12
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c3531725-710e-4c6b-a7d3-31b923cc43ca
Device Description
E. Benson Hood Laboratories Salivary Bypass Tube
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KAC | Tube, Laryngectomy | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42422 | Nasopharyngeal airway, single-use | A rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815347023649 | GS1 |