FDA UDI
In Commercial Distribution
🇺🇸 United States
Cerner FetaLink
DI: 00853023006227
·
Model: FetaLink200
·
Cerner Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cerner FetaLink
- Primary DI
- 00853023006227
- Version / Model
- FetaLink200
- Company Name
- Cerner Corporation
- Labeler DUNS
- 042410688
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-01
- Public Version
- 2
- Public Version Date
- 2023-12-05
- Public Version Status
- Update
- Public Device Record Key
- b518abeb-9c0b-4d99-b950-df367a1de491
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
- 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 |
|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44104 | Obstetrics information system application software | An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of obstetrical services and facilities. It is typically supplied for installation into a dedicated obstetrics information system or existing mainframe or decentralized computers/networks and is used in a labour ward/maternity unit and allows the electronic entry of a patient’s details of labour for viewing at different locations. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853023006227 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091251 | 000 |