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Duffel Bag

by Normatec Industries, LP

Duffel Bag (30300) is an intermittent venous compression system (FDA Class II) made by Normatec Industries, LP, cleared under FDA 510(k) K112890 on 4 Jan 2012 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00817369020668), active as of 21 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 21 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817369020668 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112890 Date4 Jan 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112890 decided 4 Jan 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00817369020668 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K013436
  2. Cleared FDA 510(k) K112890
  3. Listed FDA GUDID 00817369020668

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Intermittent venous compression system
Model / Ref / Catalog
Duffel Bag, 30300
Primary DI / UDI-DI
00817369020668
510(k) Number
FDA product code
IRP, JOW
GMDN term
Intermittent venous compression system
Device class
Class II
Regulation number
890.5650, 870.5800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intermittent venous compression systemSequential venous compression system

Cleared under the same submission (K013436)

and 8 more cleared under K013436

Cleared under the same submission (K112890)

and 8 more cleared under K112890

Similar devices

Other devices filed under FDA product code IRP (Massager, Powered Inflatable Tube).

Other devices from Normatec Industries, LP

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    Class II

  • Hyperice PRO26-St

    Class II

  • Hyperice PRO26-Tl

    Class II

  • Hyperice PRO26-Ph

    Class II

See all devices from Normatec Industries, LP →

Properties

  • Prescription use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)