FDA UDI
In Commercial Distribution
🇺🇸 United States
GAS FILTER
DI: 04953170438271
·
Model: MAJ-822
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GAS FILTER
- Primary DI
- 04953170438271
- Version / Model
- MAJ-822
- Catalog Number
- N6178601
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-22
- Public Version
- 2
- Public Version Date
- 2023-12-28
- Public Version Status
- Update
- Public Device Record Key
- 50d60198-85c6-43b2-9e71-f98a118c2684
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35069 | Medical gas pipeline system air filter | A component of a medical gas pipeline system designed as an exchangeable filter to trap the impurities of the air that is being produced by, e.g., a hospital's compressors, and that passes through it. It is composed of tightly woven materials through which the air passes and particles/impurities are trapped in the filter material removing these from the air producing clean, filtered air to meet the specified requirement. For medical air, several filters may be used in-line. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170438271 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]