FDA UDI
In Commercial Distribution
🇺🇸 United States
XI.D-V™
DI: 10885672009608
·
Model: XI.D-V
·
Oscor Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- XI.D-V™
- Primary DI
- 10885672009608
- Version / Model
- XI.D-V
- Catalog Number
- XI.D-V
- Company Name
- Oscor Inc.
- Labeler DUNS
- 101835833
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-04-17
- Public Version
- 1
- Public Version Date
- 2020-04-27
- Public Version Status
- New
- Public Device Record Key
- cf051904-2727-4560-b741-8110a366aa8b
Device Description
Disposable Extension Cable
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
- Yes
- 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 |
|---|---|---|---|---|
| IKD | CABLE, ELECTRODE | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47143 | Electrical-only medical device connection cable, single-use | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00885672009601 | GS1 | ||||
| Primary | 10885672009608 | GS1 |
Customer Contacts
- Phone
- +1(727)937-2511
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070926 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 250 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius