FDA UDI
In Commercial Distribution
🇺🇸 United States
Western/Scott Fetzer
DI: B929N4AI024MP4MP40
·
Model: N4AI-024MP4MP4
·
Western Enterprises
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Western/Scott Fetzer
- Primary DI
- B929N4AI024MP4MP40
- Version / Model
- N4AI-024MP4MP4
- Catalog Number
- N4AI-024MP4MP4
- Company Name
- Western Enterprises
- Labeler DUNS
- 148634731
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-06
- Public Version
- 3
- Public Version Date
- 2024-08-14
- Public Version Status
- Update
- Public Device Record Key
- 4da269be-8b14-4e40-9c77-af2a484abafd
Device Description
PKGD: N4-AIR-024-MP4-MP4
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 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 | B929N4AI024MP4MP40 | HIBCC |
Customer Contacts
- Phone
- 1-800-783-7890
- [email protected]