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caina 21Gx1 1/4"

by Jiangsu Caina Medical Co., Ltd

caina 21Gx1 1/4" (BC062130-W) is a Class II device made by Jiangsu Caina Medical Co., Ltd, cleared under FDA 510(k) K200027 on 9 Sep 2020 and listed in FDA GUDID since 14 May 2025 (UDI-DI 16971564462317), 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) K200027

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 Number16971564462317 UDI-DI Date14 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200027 Date9 Sep 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200027 decided 9 Sep 2020 Active
  • FDA GUDID UDI-DI 16971564462317 listed 14 May 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200027
  2. Listed FDA GUDID 16971564462317

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
caina
Generic name
Blood collection tube holder/needle
Model / Ref / Catalog
21Gx1 1/4", BC062130-W
Primary DI / UDI-DI
16971564462317
510(k) Number
FDA product code
JKA, FMI
GMDN term
Blood collection tube holder/needle
Device class
Class II
Regulation number
862.1675, 880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood collection tube holder/needle

Cleared under the same submission (K200027)

and 8 more cleared under K200027

Similar devices

Other devices filed under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection).

Other devices from Jiangsu Caina Medical Co., Ltd

See all devices from Jiangsu Caina Medical Co., Ltd →

Properties

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