Deltamax Sorbitol Mannitol Irrigation Solution DELTAMEDICA

Organization name

Deltamedica GmbH

SRN

DE-MF-000006440

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW999

  Contraindications • Methyl alcohol poisoning • Infants and toddlers Sorbitol Mannitol Irrigation Solution DELTAMEDICA contains sorbitol. For this reason, the presence of hereditary fructose intolerance or fructose-1,6-diphosphatase deficiency must be excluded prior to irrigation with Sorbitol Mannitol Irrigation Solution DELTAMEDICA. If the history is not obtainable or unclear in this regard, a fructose intolerance test is necessary prior to use. Life-threatening complications must be expected if these contraindications are not observed.
• CW999

  Side effects Due to the possible transfer of large quantities of sodium-free irrigation solution into the vascular system, changes in the electrolyte household are produced (hyponatraemia), then leading to changes in the acid-alkali household (acidosis). Symptoms of restlessness, nausea and dyspnoea occur as expressions of excessive water in the patient’s system and are early indicators of disequilibrium (TUR Syndrome).

Primary placement in Germany; available across 1 country total.

Trade name

Deltamax Sorbitol Mannitol Irrigation Solution DELTAMEDICA

UDI-DI code

04260081270082

Basic UDI-DI

B-04260081270082

Reference / catalog number

00893825

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

PVC-free bag containing sterile Sorbitol Mannitol Irrigation Solution

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 3000 MU48

• A03040299IRRIGATION KITS, SINGLE-USE - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
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