FDA UDI
In Commercial Distribution
🇺🇸 United States
Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR
DI: 04942962603171
·
Model: 60317
·
ATOM MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR
- Primary DI
- 04942962603171
- Version / Model
- 60317
- Catalog Number
- 60317
- Company Name
- ATOM MEDICAL CORPORATION
- Labeler DUNS
- 690632047
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2019-01-29
- Public Version Status
- Update
- Public Device Record Key
- b603f84d-6765-4c49-9254-d904461c0e02
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| FPL | Incubator, Neonatal Transport | General Hospital | 880.5410 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35121 | Transport infant incubator | An electrically-powered unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature; it is typically on wheels and also designed for transporting infants either outside or within the healthcare facility. It typically consists of a clear removable plastic hood with a mattress and operates using mains electricity (AC-powered) when not in use for transportation. During transport, it is connected to an ambulance electrical outlet or is battery-powered from a battery pack. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04942962603171 | GS1 | ||||
| Unit of Use | 84942962603177 | GS1 |
Customer Contacts
- Phone
- +81 488533661
- [email protected]