FDA UDI
In Commercial Distribution
🇺🇸 United States
VISERA TRACHEAL INTUBATION VIDEOSCOPE
DI: 04953170340246
·
Model: OLYMPUS LF TYPE V
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VISERA TRACHEAL INTUBATION VIDEOSCOPE
- Primary DI
- 04953170340246
- Version / Model
- OLYMPUS LF TYPE V
- Catalog Number
- N4500330
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 7
- Public Version Date
- 2023-01-16
- Public Version Status
- Update
- Public Device Record Key
- ca4485ec-17b0-4869-b7a5-9b551288370f
Device Description
LF-V TRACHEAL INTUBATION VIDEO SCOPE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "High-level Disinfectant"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44962 | Flexible video intubation laryngoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination of the trachea, and to assist the entry and positioning of an airway tube, typically an endotracheal (ET) tube, to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is thin and long to facilitate endoscope entry and the intubation procedure. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It is typically used during difficult and non-difficult intubation procedures when maintaining an airway open. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170340246 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]