FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vital Signs
DI: 10885403248962
·
Model: 7000AAO
·
Carefusion Finland 320 Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Vital Signs
- Primary DI
- 10885403248962
- Version / Model
- 7000AAO
- Catalog Number
- 7000AAO
- Company Name
- Carefusion Finland 320 Oy
- Labeler DUNS
- 367919120
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 3
- Public Version Date
- 2024-05-21
- Public Version Status
- Update
- Public Device Record Key
- 87f36256-2054-45a9-98d0-e7c1705335f6
- Distribution End Date
- 2022-03-31
Device Description
Fetal Spiral Electrode For Corometrics
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HGP | ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR | Obstetrics/Gynecology | 884.2675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35038 | Foetal scalp electrode, spiral | A sterile electrical conductor designed to transmit electric signals from the foetal scalp to an intrapartum monitor. The device is a spiralled (either single- or double-helix) metallic electrode with a sharp tip that is directly inserted into the foetal scalp with a screwing action; and an adaptor cable that may include a transducer. The electrode penetrates into the scalp up to 2.5 mm (0.1 inch); it is usually inserted with a dedicated applicator that may be included. The electrode is typically used to monitor a foetal physiologic signal (e.g., heart rate) during labour (intrapartum) after rupture of the amniotic sac. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403248960 | GS1 | Case | 50 | Not in Commercial Distribution | 2022-03-31 |
| Primary | 10885403248962 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 100 Degrees Fahrenheit