FDA UDI
In Commercial Distribution
🇺🇸 United States
Western/Scott Fetzer
DI: B929C4AI048FHTFHT0
·
Model: C4AI-048FHTFHT
·
WESTERN/SCOTT FETZER COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Western/Scott Fetzer
- Primary DI
- B929C4AI048FHTFHT0
- Version / Model
- C4AI-048FHTFHT
- Catalog Number
- C4AI-048FHTFHT
- Company Name
- WESTERN/SCOTT FETZER COMPANY
- Labeler DUNS
- 148634731
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-06
- Public Version
- 2
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- 49f57ed5-3504-42f0-8e79-6d099abaa82c
Device Description
PKGD: C4-AIR-048-FHT-FHT
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 | B929C4AI048FHTFHT0 | HIBCC |
Customer Contacts
- Phone
- 1-800-783-7890
- [email protected]