Draeger medical technology
In-vitro diagnostics systems, infection-control consumables, and home-care equipment documented with method conditions, UDI traceability, and ISO 13485:2016 quality controls for hospital and laboratory buyers.
Reference specifications
Expand each group for throughput, sterility, and home-care deployment fields. Exact values ship with the model-specific IFU and destination-market dossier.
| CLIA complexity tier | Moderate / high — certificate type confirmed per assay panel |
|---|---|
| Throughput | Tests/hour, median TAT, and 99th-percentile TAT listed per analyzer family |
| LIS integration | HL7 v2.5.1 ORM/ORU · ASTM E1394 · FHIR Lab IG · Epic Beaker / Cerner Path middleware |
| QC framework | CAP / API / EQA · Levey-Jennings · Westgard rules · bias % and CV % |
| Precision reference | CLSI EP05 method comparison package available on request |
| Sterility assurance | SAL 10⁻⁶ where sterile barrier claimed · ISO 11607 packaging validation |
|---|---|
| Reprocessing route | Steam / EO / vapor H₂O₂ compatibility stated on IFU — never assumed across SKUs |
| Indicators | Class 5 chemical / Class 6 emulating / BI spore log fields where applicable |
| UDI & lot | UDI-DI / UDI-PI · GUDID linkage · cold-chain excursion logs for lot-sensitive items |
| SPD workflow | Decontamination → assembly → sterilization → storage → distribution with tray trace |
| Deployment path | Hospital-to-home discharge bundle vs long-term care install — documented separately |
|---|---|
| Caregiver training | Teach-back checklist · multilingual IFU · 30-day check-in call option |
| Reimbursement fields | HCPCS Level II crosswalk · DME MAC region notes · prior-auth checklist on request |
| Connectivity | FHIR observation push · Bluetooth LE pairing · HIPAA-aligned cloud options where offered |
| Durability | Clinical-grade cycle counts and recall history fields attached to each reference |
Engineering controls
510(k) summaries, CE Mark under MDR 2017/745, and destination-market letters packaged per reference.
Linearity, precision (CLSI EP05), bias, reportable range, and acceptance criteria with uncertainty notes.
GS1 issuing agency fields, GUDID linkage, and complaint/CAPA hooks for PMS and vigilance.
HL7 FHIR R4, LIS middleware, and cybersecurity SBOM / MDS² packages for connected systems.
PM intervals, NIST-traceable calibration, parts depots, and MTTR targets for Tier-1 facilities.
IEC 62366-1 usability evidence and teach-back materials for home and rehab deployments.
Care settings
Scroll the care-setting cards — each maps to laboratory, infection-control, or home-care product families with distinct documentation packs.
Central lab automation, SPD consumables, discharge-to-home bundles.
High-complexity assays, CAP proficiency packages, LIS bidirectional flows.
Sterile barrier kits, rapid turnover infection-control SKUs, compact analyzers.
Point-of-care panels, clinic-ready consumables, caregiver training kits.
Mobility aids, monitoring supplies, infection-control routines for LTC.
Hospital-to-home equipment, adherence tracking fields, 24/7 support line.
Buyer voices
Composite review principles for illustration — not named-customer endorsements and not outcome claims for any SKU.
“We needed CLSI EP05 precision packages and HL7 middleware notes before the value-analysis vote. Draeger’s dossier arrived with acceptance criteria and uncertainty already filled.”
“Infection-control SKUs included ISO 11607 packaging validation and tray-level UDI fields. That cut our SPD onboarding questions in half.”
“Home-care discharge bundles came with teach-back checklists and HCPCS crosswalk notes. Procurement could model TCO without chasing three vendors.”
Tell us the product family, destination market, and decision timeline. We return IFU, performance fields, and service options without unsupported outcome claims.
Speak to a Clinical Specialist