FDA UDI
In Commercial Distribution
🇺🇸 United States
Nimbus
DI: 00817170020017
·
Model: HS-001
·
INFUTRONIX LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Nimbus
- Primary DI
- 00817170020017
- Version / Model
- HS-001
- Catalog Number
- HS-001
- Company Name
- INFUTRONIX LLC
- Labeler DUNS
- 079821136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 66d00cf0-c30c-45c1-93c7-2278a2767008
Device Description
Administration set
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
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817170020011 | GS1 | case | 4 | Not in Commercial Distribution | 2016-10-31 |
| Package | 10817170020014 | GS1 | Inner pack | 50 | Not in Commercial Distribution | 2016-10-31 |
| Primary | 00817170020017 | GS1 | ||||
| Package | 30817170020018 | GS1 | Inner pack | 20 | In Commercial Distribution | |
| Package | 40817170020015 | GS1 | Case | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 508-650-2007
- [email protected]