Glossary entry (derived from question below)
English term or phrase:
for prescription use only
Romanian translation:
exclusiv utilizării pe bază de prescripție medicală
Added to glossary by
danieline
Nov 8, 2023 18:08
7 mos ago
15 viewers *
English term
for prescription use only
English to Romanian
Medical
Medical: Instruments
The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
Proposed translations
(Romanian)
5 +3 | exclusiv utilizării pe bază de prescripție medicală | Iosif JUHASZ |
Proposed translations
+3
4 mins
Selected
exclusiv utilizării pe bază de prescripție medicală
· Dispozitivul este destinat exclusiv utilizarii pe baza de prescriptie medicala.
4 KudoZ points awarded for this answer.
Comment: "Multumesc!"
Reference comments
18 mins
Reference:
pot fi achiziționate doar pe bază de rețetă
if the device is for prescription use only, then the symbol (or narrative analog) is a regulatory requirement. Failure to have it when required will result in the device being misbranded (i.e., not legally labeled).
https://www.fda.gov/about-fda/economic-impact-analyses-fda-r...
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192137.pdf
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Note added at 57 mins (2023-11-08 19:05:26 GMT)
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Da, se aplică și la dispozitive
de exemplu un tensiometru sau un termometru este over-the-counter, se achiziționează liber
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Note added at 1 hr (2023-11-08 19:08:22 GMT)
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De exemplu aici:
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192137.pdf
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
este bifata casuta
Prescription Use (Part 21 CFR 801 Subpart D)
https://www.fda.gov/about-fda/economic-impact-analyses-fda-r...
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192137.pdf
--------------------------------------------------
Note added at 57 mins (2023-11-08 19:05:26 GMT)
--------------------------------------------------
Da, se aplică și la dispozitive
de exemplu un tensiometru sau un termometru este over-the-counter, se achiziționează liber
--------------------------------------------------
Note added at 1 hr (2023-11-08 19:08:22 GMT)
--------------------------------------------------
De exemplu aici:
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192137.pdf
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
este bifata casuta
Prescription Use (Part 21 CFR 801 Subpart D)
Note from asker:
Sunt niste monitoare de functii vitale. |
Multumesc pentru explicatii. |
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