KIRO Set

GUDID 08437014572100

The KIRO SET is a sterile, single-use, disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy compounding device for the transfer of fluids into sterile powder drug vials for reconstitution of intravenous drugs or into sterile medication containers for intravenous drug administration.

KIRO GRIFOLS SL.

Compounding transfer set
Primary Device ID08437014572100
NIH Device Record Key10260b7f-fcac-47b8-bbbb-715832102e40
Commercial Distribution StatusIn Commercial Distribution
Brand NameKIRO Set
Version Model Number100801
Company DUNS464246224
Company NameKIRO GRIFOLS SL.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com
Phone1-256-500-4339
Emailsupportkirousa@grifols.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108437014572100 [Primary]
GS108437014572117 [Package]
Package: Shelf Box [10 Units]
In Commercial Distribution
GS118437014572107 [Package]
Package: Shipper Box [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHISet, I.V. Fluid Transfer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2024-09-10
Device Publish Date2016-11-11

Devices Manufactured by KIRO GRIFOLS SL.

08437014572100 - KIRO Set2024-09-10The KIRO SET is a sterile, single-use, disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy compounding device for the transfer of fluids into sterile powder drug vials for reconstitution of intravenous drugs or into sterile medication containers for intravenous drug administration.
08437014572100 - KIRO Set2024-09-10 The KIRO SET is a sterile, single-use, disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy
08437014572209 - KIRO Oncology US2024-09-10 KIRO Oncology is an automated pharmacy compounding device (PCD) for the preparation of compounded sterile preparations (CSPs). K
08437014572308 - KIRO Link2024-09-10 KIRO Link is a software intended to enter, store, convert, transfer and display the data to support the integration and workflow
08437014572223 - KIRO Fill US2019-12-24 KIRO Fill is an automated pharmacy compounding device (PCD) for the preparation of non-hazardous Compounded Sterile Preparations

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