FDA UDI
In Commercial Distribution
🇺🇸 United States
Vital Signs™
DI: 10889483588406
·
Model: 7000AAO
·
AirLife Finland Oy
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Vital Signs™
- Primary DI
- 10889483588406
- Version / Model
- 7000AAO
- Catalog Number
- 7000AAO
- Company Name
- AirLife Finland Oy
- Labeler DUNS
- 368457563
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-31
- Public Version
- 1
- Public Version Date
- 2025-04-08
- Public Version Status
- New
- Public Device Record Key
- dee7cd36-803d-4b0f-adcb-7ea5eb69fb91
Device Description
Vital Signs™ 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 | 20889483588403 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 10889483588406 | GS1 | ||||
| Previous | 10190752142176 | GS1 |
Customer Contacts
- Phone
- (800)433-2797
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K792669 | 000 |