Technical Data Sheet
Plum Eyewash 0.9% Sodium Chloride
1. Identification of the product and the company
1.1. Product identifier and intended use.
Trade Name: Plum Eyewash 0.9% Sodium Chloride and Plum Eyewash 0.9% Sodium Chloride
QuickRinse
Intended Use: The products are intended to be used as first aid products for eye irrigation.
Expiry date: Printed on the bottle label/ampoule.
1.2. Details of the supplier of the data sheet
Manufacturer
Company: Plum Safety ApS
Address: Mandelalleen 1
Zip code: 5610
City: Assens
Country DENMARK
E-mail
[email protected]Phone +45 6916 9600
Fax +45 6916 9630
1.3 Legislative information
General information: As the products are class 1s sterile medical devices according to Council Directive
93/42/EEC of 14 June 1993 concerning medical devices, they are certified by the Notified
Body, DNV Product Assurance AS. No Safety Data Sheet is required for medical
devices.
The products shall not be classified as hazardous according to the classification and
labeling rules for substance and mixtures.
Plum Safety ApS is certified according to ISO 13485:2016 Medical devices -- Quality
management systems -- Requirements for regulatory purposes.
1.4 Instruction for use: Mono eye cup (200, 500, 1000 ml) Duo eye cup (500, 1000 ml)
Ampoule (20 ml)
- Do not reuse.
- Do not use if damaged.
- Recommended temperature when used
Technical Data Sheet
Plum Eyewash 0.9% Sodium Chloride
2. General information about the product
Material requirements: The materials in these products have been judged biocompatible according the
requirements of ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1:
Evaluation and testing within a risk management process.
Bottle, label and eye cup dimensions.
20 ml ampoule 200 ml bottle 500 ml bottle 1000 ml bottle
Bottle material Polyethylene Polyethylene without Polyethylene without Polyethylene without
without additives additives additives additives
The bottle/ampoule 20.0-20.5 201-207 505-512 1005-1020
contains [ml]
Bottom Ø [mm] 21 58.5 78 90
Height [mm] 104 129.6 183 229
3. Side effects and malfunction
Side effects and malfunction: The products are designed as a first aid product for eye irrigation. If side effects or
malfunctions are experienced, please report these to Plum Safety ApS,
[email protected] or
phone +45 6916 9600, so that necessary remedial measures can be initiated.
Serious adverse effects should always be reported to a relevant competent authority.
4. Storage
Storage:
Shelf life: 42 months from manufacturing date.
Installation: Please refer to the pictogramm on the label:
Mounting stations and boxes: Please visit https://plum.eu/products/firstaid/eye-wash
5. Other information
Version history and indication of changes
Version Revision date Responsible Changes
1.3 25-05-2021 CL 1.2, 1.3, 3, 5
1.2 30-09-2020 CL 5
1.1 03-06-2020 CL / VWB 5
1.0 14-04-2020 CL /VWB
Other information Additional information can be obtained by contacting [email protected] or by telephone +45 6916 9600
TDS prepared by:
Company: Plum Safety ApS
Address: Mandelalleen 1
Zip code: 5610
City Assens
Country: DENMARK
E-mail:
[email protected] Phone: +45 6916 9600
Fax: +45 6916 9630
Document Language: English
