FDA UDI
In Commercial Distribution
🇺🇸 United States
KIRO Link
DI: 08437014572308
·
Model: 1006
·
KIRO GRIFOLS SL.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- KIRO Link
- Primary DI
- 08437014572308
- Version / Model
- 1006
- Company Name
- KIRO GRIFOLS SL.
- Labeler DUNS
- 464246224
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-07
- Public Version
- 3
- Public Version Date
- 2024-09-10
- Public Version Status
- Update
- Public Device Record Key
- f9aa368d-4ecb-4b08-8d7b-0c3f3ec04ace
Device Description
KIRO Link is a software intended to enter, store, convert, transfer and display the data to support the integration and workflow management functionalities of Pharmacy Compounding Devices (PCDs) with customer site softwares such as Computerized Physician Order Entry (CPOE), logistics, quality control and compounding assisting software. KIRO Link is intended to be used only by qualified pharmacy personnel.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUG | Medical Device Data System | General Hospital | 880.6310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63888 | Medical equipment non-clinical data monitoring software | An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment (e.g., sterilizers/disinfectors, refrigerators) to assist process management. It is not intended for control of equipment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437014572308 | GS1 |
Customer Contacts
- Phone
- 1-256-500-4339
- [email protected]