KERASAVE

GUDID 08021118001408

Kerasave is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium pyruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 100 ug/ml gentamicin sulfate and 200 ug/ml streptomycin sulfate, and a tablet to be dissolved in the medium prior to use, corresponding to 2.5 ug/ml of amphotericin B. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator. It provides basic nutrients for cell maintenance.

AL.CHI.MI.A. SRL

Corneal storage medium
Primary Device ID08021118001408
NIH Device Record Key4854c876-98c1-45a8-83c4-aca6569bb56c
Commercial Distribution StatusIn Commercial Distribution
Brand NameKERASAVE
Version Model NumberKER 001-00
Company DUNS655640332
Company NameAL.CHI.MI.A. SRL
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com
Phone+390498962074
Emailinfo@alchimiasrl.com

Device Dimensions

Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *2-8°C

Device Identifiers

Device Issuing AgencyDevice ID
GS108021118001408 [Primary]
GS118021118001405 [Package]
Package: Carton box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QCWCorneal Storage Media With Preservatives Including Anti-Fungal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-13
Device Publish Date2022-12-05

Trademark Results [KERASAVE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KERASAVE
KERASAVE
97613891 not registered Live/Pending
Oftalone, Inc
2022-09-29

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