FDA UDI
In Commercial Distribution
🇺🇸 United States
BR Surgical, LLC
DI: 00840183502997
·
Model: BR900-7955
·
BR Surgical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BR Surgical, LLC
- Primary DI
- 00840183502997
- Version / Model
- BR900-7955
- Catalog Number
- BR900-7955
- Company Name
- BR Surgical, LLC
- Labeler DUNS
- 134781207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-23
- Public Version
- 1
- Public Version Date
- 2024-07-31
- Public Version Status
- New
- Public Device Record Key
- 8266b65b-e008-43b1-9cd5-7178f9f6af10
Device Description
Pressure Hose (10ft) and Stainless Nozzle Fitting (for use with atomizer bottles) for ENT treatment cabinet
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ETF | Unit, Examining/Treatment, Ent | Ear, Nose, Throat | 874.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40484 | Medical air low pressure hose | A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed medical air from a medical air cylinder/terminal unit to a medical device that functions with medical air (e.g., ventilator, anaesthesia unit, anaesthesia system, suctions system, or other medical air dependent device). The gas pressure in the tubing will be low, a "working pressure", having been reduced by a regulator from a higher pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840183502997 | GS1 |
Customer Contacts
- Phone
- 1-904-642-1366
- [email protected]