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Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level Resware BI 20 S

by Sysmed (China) Co., Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06955623020185 UDI-DI Date6 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level
Generic Name
Intensive-care patient transport system, ventilatory support, adult
Model / Reference
Resware BI 20 S
Primary DI / UDI-DI
06955623020185
510(k) Number
FDA Product Code
BZD
GMDN Term
Intensive-care patient transport system, ventilatory support, adult
Device Class
Class II
Regulation Number
868.5905
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K192177)

Other devices from Sysmed (China) Co., Ltd

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Properties

  • Serial Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No