FDA UDI
In Commercial Distribution
🇺🇸 United States
AIR BARRIER SYSTEM BLOWER
DI: 00842430115462
·
Model: 600-0017
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AIR BARRIER SYSTEM BLOWER
- Primary DI
- 00842430115462
- Version / Model
- 600-0017
- Catalog Number
- 600-0017
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-19
- Public Version
- 4
- Public Version Date
- 2022-02-02
- Public Version Status
- Update
- Public Device Record Key
- b559ca8c-a71f-4e5b-9a25-ed78438514f4
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ORC | Air Filter Portable Apparatus | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36138 | Surgical laminar airflow unit | An electrically-powered device designed to filter air [usually through a high-efficiency particulate air (HEPA) filter] in surgical theatres by producing a directed, non-turbulent flow of clean air to provide an area free of contaminants and reduce the risk of patient infection. It may be mobile (on wheels) or fixed [e.g., to the ceiling], and provides a curtain of fast moving air that helps to delineate the sterile field; some types allow connection of a hose with a nozzle designed to be adhered to the patient to direct the filtered air across the surgical site. An operating light or light system may be mounted to this unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430115462 | GS1 | ||||
| Previous | 00869284000249 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 100 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 100 Percent (%) Relative Humidity