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Sea-Long Medical Systems 5200

by Sea-Long Medical Systems, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850052737054 UDI-DI Date12 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sea-Long Medical Systems
Generic Name
Oxygen administration hood, adult
Model / Ref / Catalog
5200
Primary DI / UDI-DI
00850052737054
510(k) Number
FDA Product Code
CBF
GMDN Term
Oxygen administration hood, adult
Device Class
Class II
Regulation Number
868.5470
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K010659)

Other devices from Sea-Long Medical Systems, LLC

See all devices from Sea-Long Medical Systems, LLC →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No