Skip to content

Medline DYNJ757NB

by Medline Industries, Inc.

Medline DYNJ757NB is a medical device (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Medline Industries, Inc., cleared under FDA 510(k) K042758 on 29 Aug 2005 and listed in FDA GUDID since 29 Oct 2021 (UDI-DI 10888277652361), active as of 23 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 23 Oct 2026

Documents

510(k) K042758

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10888277652361 UDI-DI Date29 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042758 Date29 Aug 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042758 decided 29 Aug 2005 Active
  • FDA GUDID UDI-DI 10888277652361 listed 29 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042758
  2. Listed FDA GUDID 10888277652361

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medline
Generic name
Progastrin-releasing peptide (ProGRP) IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
DYNJ757NB
Primary DI / UDI-DI
10888277652361
510(k) Number
FDA product code
BZG
GMDN term
Progastrin-releasing peptide (ProGRP) IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
868.1840
GUDID distribution status
In Commercial Distribution

Related devices

Category: Progastrin-releasing peptide (ProGRP) IVD, kit, fluorescent immunoassay

Cleared under the same submission (K042758)

and 8 more cleared under K042758

Similar devices

Other devices filed under FDA product code BZG (SPIROMETER, DIAGNOSTIC).

Other devices from Medline Industries, Inc.

See all devices from Medline Industries, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)