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Inrad 40050

by Inrad

Inrad 40050 is an intravenous fluid bag spike (FDA Class II; FDA product code LHI, Set, I.V. Fluid Transfer) made by Inrad, cleared under FDA 510(k) K980587 on 17 Apr 1998 and listed in FDA GUDID since 1 Dec 2016 (UDI-DI 00817295020558), active as of 22 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 22 Oct 2026

Documents

510(k) K980587

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817295020558 UDI-DI Date1 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK980587 Date17 Apr 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K980587 decided 17 Apr 1998 Active
  • FDA GUDID UDI-DI 00817295020558 listed 1 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K980587
  2. Listed FDA GUDID 00817295020558

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Inrad
Generic name
Intravenous fluid bag spike
Model / reference
40050
Primary DI / UDI-DI
00817295020558
510(k) Number
FDA product code
LHI
GMDN term
Intravenous fluid bag spike
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intravenous fluid bag spike

Similar devices

Other devices filed under FDA product code LHI (Set, I.V. Fluid Transfer).

Other devices from Inrad

  • Inrad 53220

    Class I

  • Inrad 53222

    Class I

  • Inrad 53218

    Class I

  • Inrad 41222

    Class I

See all devices from Inrad →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)