FDA UDI
In Commercial Distribution
🇺🇸 United States
NICO Myriad
DI: 00816744028398
·
Model: NN-8039
·
NICO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NICO Myriad
- Primary DI
- 00816744028398
- Version / Model
- NN-8039
- Company Name
- NICO CORPORATION
- Labeler DUNS
- 829838288
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 4
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- 72b38b14-90f6-4d07-a54f-e6f24f22acdb
Device Description
Specimen Infusion Valve (SIV) 0.760 mm ID Metering Line
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
- Yes
- 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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63212 | Surgical suction system Y-piece valve-connector | A noninvasive tubular device intended to provide a connection between devices so that it is integrated within the tubing line of a suction assembly (e.g., of a tissue morcellation system with suction) where it can be used to introduce fluid into the suction line, typically to bathe a tissue sample captured within a filter. The device provides a channel for continuous suction and a side connector with an integrated valve to allow infusion of fluid without loss of suction; it may include a length of infusion line tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816744028395 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00816744028398 | GS1 |
Customer Contacts
- Phone
- 317-660-7118
- [email protected]