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Blood Collection Set 8950

by Dynarex Corp.

Blood Collection Set 8950 is a Class II device made by Dynarex Corp., cleared under FDA 510(k) K151991 and listed in FDA GUDID since 6 Aug 2018 (UDI-DI 00616784895024), 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) K151991↗

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 Number00616784895024 UDI-DI Date6 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK151991 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151991 Active
  • FDA GUDID UDI-DI 00616784895024 listed 6 Aug 2018 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Blood Collection Set
Generic name
Non-fixed blood collection needle
Model / reference
8950
Primary DI / UDI-DI
00616784895024
510(k) Number
FDA product code
FPA
GMDN term
Non-fixed blood collection needle
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Non-fixed blood collection needle

Cleared under the same submission (K151991)

and 8 more cleared under K151991

Similar devices in this category

Other devices filed under Non-fixed blood collection needle.

Other devices from Dynarex Corp.

See all devices from Dynarex Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)