FDA UDI
In Commercial Distribution
🇺🇸 United States
GRI-FILL 2 Ways Set
DI: 08426314575768
·
Model: GRI-FILL 2 Ways Set
·
LABORATORIOS GRIFOLS SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GRI-FILL 2 Ways Set
- Primary DI
- 08426314575768
- Version / Model
- GRI-FILL 2 Ways Set
- Company Name
- LABORATORIOS GRIFOLS SA
- Labeler DUNS
- 463720681
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-15
- Public Version
- 2
- Public Version Date
- 2025-03-18
- Public Version Status
- Update
- Public Device Record Key
- 6bd3664a-6786-46c0-b5ae-2e391238bdaa
Device Description
Gri-fill 2 Ways Set is a fluid transfer set for use with the Gri-fill pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. Gri-fill 2 Ways Set is made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Set is available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the Gri-fill 2 Ways 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
- 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 |
|---|---|---|---|---|
| 43324 | Fluid transfer set, general-purpose | A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426314575768 | GS1 | ||||
| Package | 28426314575762 | GS1 | Box | 15 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050339 | 000 |