FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00840682103510
·
Model: NMT Regional Block Adapter, 888417
·
GE Healthcare Finland Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00840682103510
- Version / Model
- NMT Regional Block Adapter, 888417
- Company Name
- GE Healthcare Finland Oy
- Labeler DUNS
- 401966697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-16
- Public Version
- 4
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 607abb56-e345-497a-b930-fd89cd48858b
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| KOI | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC | Anesthesiology | 868.2775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59691 | Neuromuscular transmission regional anaesthesia block adaptor | A device intended to conduct electrical signals between an integrated electrode connection clip and an injection needle on a patient’s body, via a neuromuscular transmission (NMT) sensor cable, and subsequently to a patient monitoring module for the localization of a nerve in an area of the body for the administration of regional anaesthesia. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682103510 | GS1 |
Customer Contacts
- Phone
- +1(800)558-5120
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051635 | 000 |