FDA UDI
In Commercial Distribution
🇺🇸 United States
GRI-FILL PERISTALTIC SET
DI: 08426314387972
·
Model: -
·
LABORATORIOS GRIFOLS SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GRI-FILL PERISTALTIC SET
- Primary DI
- 08426314387972
- Version / Model
- -
- Company Name
- LABORATORIOS GRIFOLS SA
- Labeler DUNS
- 463720681
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-21
- Public Version
- 1
- Public Version Date
- 2018-12-24
- Public Version Status
- New
- Public Device Record Key
- 4025e098-0de7-45b7-878a-7b2c2d9e9dfd
Device Description
Gri-fill Peristaltic Set is an IV fluid transfer set to be used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one source substance is channeled repeatedly to an IV container. It consists of a silicone tube linking a male luer-lock connector and a spike (with a 0.2 µm hydrophobic air filter), and a female luer-lock connection.
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 |
|---|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41646 | Compounding transfer set | A collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426314387972 | GS1 | ||||
| Package | 28426314387976 | GS1 | 25 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162216 | 000 |