NT
AT393-EMAR-393-12/10/2022
8
UNDESIRABLE SIDE EFFECTS
The studies carried out have not demonstrated any adverse effects on the health of patients.
9
PRODUCT COMPLIANCE
FILT
’RAY
filters:
•
are sterilised by gamma irradiation in accordance with NF EN ISO 11137 standard. Do not resterilise.
•
are class Is medical devices compliant with European Regulation EU 2017/745. CE marking: year 2022.
•
have international drinking water compliance validations (ACS - France, KTW - Germany, WRAS - United Kingdom).
I MANUFACTURER DETAILS
FILT
’RAY
filters are manufactured by:
Registered Office:
AQUATOOLS
| 11, rue Lobineau | 75006 PARIS | France
Main establishment:
AQUATOOLS
| 18, rue du Maréchal Foch | 80130 FRIVILLE | France
1.
For more information, visit our website: www.aqua-tools.com.
or contact us:
tel.:
+ 33 (0)1 39 75 02 20 -
E-mail:
2.
The “Scientific and Technical Validation Guideline” relating to filters is available on request.
3.
The paper version of the notices remains available on request.
4.
Any serious incident must be notified to the manufacturer and to the competent authority of the Member State where
the user and/or the patient resides.
Reference:
A sterilising grade filter is defined in the "American Standard Test Method ASTM F838-20 and FDA - Guidance for Industry
- Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice
Product label - meaning of the pictograms
Catalogue reference
Batch code
Expiration date
STERILIZE
Device sterilised by irradiation
Do not resterilise
Do not use if the packaging is damaged.
Manufacturer's address
Meets general safety and performance
requirements
Consult the precautions for use
Sterile barrier system only.
Medical Device
Unique Device Identifier
Do not reuse
Commissioning date
Decommissioning date
Use-by date after commissioning
1M: 1 month - 2M: 2 months - 3M: 3 months - 4M: 4 months
B
A
2
1
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Summary of Contents for FILT'RAY
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