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BodyMed BDMEFS60

by Boxout, LLC

BodyMed BDMEFS60 is an ENFit oral/enteral syringe (FDA Class II; FDA product code PNR, Enteral Syringes With Enteral Specific Connectors) made by Boxout, LLC, cleared under FDA 510(k) K182649 on 9 Nov 2018 and listed in FDA GUDID since 23 May 2023 (UDI-DI 00815991025006), 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) K182649

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 Number00815991025006 UDI-DI Date23 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182649 Date9 Nov 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182649 decided 9 Nov 2018 Active
  • FDA GUDID UDI-DI 00815991025006 listed 23 May 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182649
  2. Listed FDA GUDID 00815991025006

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BodyMed
Generic name
ENFit oral/enteral syringe, single-use
Model / reference
BDMEFS60
Primary DI / UDI-DI
00815991025006
510(k) Number
FDA product code
PNR
GMDN term
ENFit oral/enteral syringe, single-use
Device class
Class II
Regulation number
876.5980
GUDID distribution status
In Commercial Distribution

Related devices

Category: ENFit oral/enteral syringe, single-use

Cleared under the same submission (K182649)

and 8 more cleared under K182649

Similar devices in this category

Other devices filed under ENFit oral/enteral syringe, single-use.

Other devices from Boxout, LLC

See all devices from Boxout, LLC →

Properties

  • Supplied sterile
  • Single use
  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)