FDA UDI
In Commercial Distribution
🇺🇸 United States
Bausch + Lomb
DI: 00757770422005
·
Model: N5941 1A
·
Bausch & Lomb Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bausch + Lomb
- Primary DI
- 00757770422005
- Version / Model
- N5941 1A
- Catalog Number
- N5941 1A
- Company Name
- Bausch & Lomb Incorporated
- Labeler DUNS
- 196603781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 3d2e23a3-2633-4694-a6c7-7fc8d867192d
Device Description
SILICONE TUBE .012"x.025"x50FT
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GBX | Catheter, Irrigation | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10217 | Surgical suction system | An assembly of devices designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a surgical site by means of suction during surgical procedures. It generally consists of a mains electricity (AC-powered) suction pump, a regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The vacuum capability should be at least 400 mm Hg; free flow rates may be as high as 35 litter/min. The system is mainly used when suction from a central vacuum system is not available or appropriate. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00757770422005 | GS1 |