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Dream Sock Duo Monitoring System, Sweet Clementine OSS 3.0-M1; OBL 3.0-M1

by Owlet Baby Care, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00810099091267 UDI-DI Date17 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Dream Sock Duo Monitoring System, Sweet Clementine
Generic Name
Multiple vital physiological parameter monitoring system, home-use
Model / Reference
OSS 3.0-M1, OBL 3.0-M1
Primary DI / UDI-DI
00810099091267
FDA Product Code
QYU
GMDN Term
Multiple vital physiological parameter monitoring system, home-use
Models / Variants
Device Class
Class II
Regulation Number
870.2705
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

From the manufacturer

Manufacturer's product page: Dream Duo + Floor Stand

Other devices from Owlet Baby Care, Inc.

See all devices from Owlet Baby Care, Inc. →

Properties

  • Over-the-Counter
  • Serial 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
  • Lot / Batch Number: No
  • Expiration Date: No