FDA UDI
In Commercial Distribution
🇺🇸 United States
HOSE ASSEMBLY, STD
DI: B1285107285H50
·
Model: 5107285H5
·
Bay Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HOSE ASSEMBLY, STD
- Primary DI
- B1285107285H50
- Version / Model
- 5107285H5
- Catalog Number
- 5107285H5
- Company Name
- Bay Corporation
- Labeler DUNS
- 095472262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-26
- Public Version
- 1
- Public Version Date
- 2023-10-04
- Public Version Status
- New
- Public Device Record Key
- 8079899f-1d2c-4413-9a82-f6565a338358
Device Description
O2 Low Pressure Hose Assembly
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
- Yes
- 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 |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42039 | Oxygen low pressure hose | A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed oxygen (O2) from an O2 terminal unit or O2 cylinder to a medical device that functions with O2 (e.g., ventilators, anaesthesia unit, analgesia unit, and other O2 dependent respiratory device). The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high 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 | B1285107285H50 | HIBCC |
Customer Contacts
- Phone
- 440-835-2212
- [email protected]