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Peakme Ck-W358

by Shenzhen Changkun Technology Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06951727602883 UDI-DIDate23 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Peakme
Generic Name
Blood pressure alarm
Model / Reference
CK-W358
Primary DI / UDI-DI
06951727602883
510(k) Number
FDA Product Code
DXN
GMDN Term
Blood pressure alarm
Device Class
Class II
Regulation Number
870.1130
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K193386)

Show all (12)

Other devices from Shenzhen Changkun Technology Co., Ltd.

See all devices from Shenzhen Changkun Technology Co., Ltd. →

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No