The PrisMax control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy

🔍 What we found about this product

A factual report of what public registries and product databases returned for this EAN. We do not authenticate products or issue safety verdicts — we only report what we found.

Identifier checks

• 📋 EAN format: the GTIN-13 mod-10 checksum is consistent with the GS1 standard (format check only; does not authenticate the physical product)
• 📋 GS1 prefix 008 indicates the issuing office in United States / Canada (this is the country where the brand owner registered the EAN; it is not necessarily where the product was manufactured. Source: GS1 country code list)
• 📋 Brand entries found: no entry for BAXTER HEALTHCARE CORPORATION in the Wikidata brand registry (our coverage of Wikidata is partial; absence is not a finding either way)
• 📋 Listed in 0 of the public product catalogues we check (our catalogue coverage is partial; absence is not a finding either way)

Registry scans

• 📋 Recall registry scan returned 1 matching record (see recall section above for details. Sources scanned: CPSC, FDA, RAPEX, Health Canada, NHTSA)
• 📋 Substance database scan returned 0 matches (sources scanned: ECHA SVHC, REACH Annex XVII, EU RoHS, Stockholm POPs, CLP Annex VI. Coverage gaps exist)
• 📋 Banned-ingredient scan (EU Cosmetic Annex II) returned 0 matches (source: EU Reg. 1223/2009. Scanned against available label text only)
• 📋 Certifications listed in our databases: none found (registries scanned: EU Ecolabel, US ENERGY STAR, US EPA Safer Choice. Many legitimate products are not enrolled in these schemes)
• 📋 Medical device registry: listed in US FDA GUDID (entry)

Sources scanned: GS1 country prefix · Wikidata brand registry · Open Beauty / Food Facts · USDA FDC Branded Foods · Nudger GTIN dataset · EU Safety Gate (RAPEX) · US CPSC · US FDA recalls · Health Canada Recalls · NHTSA recalls · ECHA SVHC · REACH Annex XVII · EU RoHS · Stockholm POPs · CLP Annex VI · EU Cosmetic Annex II · EU Ecolabel · US ENERGY STAR · US EPA Safer Choice · US FDA GUDID · EU EUDAMED.
Last refreshed: 2026-09-08.

About this section. We aggregated what we found across 24 public registries and product databases as of 2026-09-08. This is not an authentication, certification, or safety endorsement. Coverage gaps in our source data exist. For definitive verification, please contact the manufacturer or the relevant regulator directly.