FDA Product Code GIM: Tubes, Vacuum Sample, With Anticoagulant
FDA product code GIM covers vacuum sample tubes containing anticoagulants used for hematology testing.
These evacuated tubes contain EDTA, heparin, or sodium citrate anticoagulants that prevent blood clotting during collection and transport, preserving cell morphology and enabling accurate complete blood counts, coagulation studies, and blood film preparation.
GIM devices are Class II medical devices, regulated under 21 CFR 862.1675 and reviewed by the FDA Hematology panel.
Leading manufacturers include Sherwood Medical Industries, Sherwood Medical Co. and Bd Becton Dickinson Vacutainer Systems Preanalytic.
39
Total
39
Cleared
91d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Tubes, Vacuum Sample, With Anticoagulant Devices (Product Code GIM)
39 devices
Cleared
Oct 31, 2024
BD Vacutainer® Citrate Blood Collection Tubes
Becton, Dickinson and Company
Hematology
259d
Cleared
Nov 27, 2023
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
Becton, Dickinson and Company
Hematology
277d
Cleared
Aug 25, 2023
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
Becton, Dickinson and Company
Hematology
641d
Cleared
Jun 22, 2017
TransFix/EDTA Vacuum Blood Collection Tubes
Caltag Medsystems, Ltd.
Immunology
266d
Cleared
Jul 31, 2008
CYTO-CHEX BCT
Streck
Hematology
154d
Cleared
Sep 18, 2001
DS30 HCY BLOOD COLLECTION TUBES
Drew Scientific , Ltd.
Chemistry
69d
Cleared
Jun 17, 1997
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
Becton Dickinson Vacutainer Systems
Chemistry
57d
Cleared
May 02, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
Greiner America, Inc.
Chemistry
30d
Cleared
Jun 30, 1995
LOK-ON NEEDLE DISPOSAL SYSTEM
Becton Dickinson Vacutainer Systems
Chemistry
67d
Cleared
Feb 06, 1995
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
91d
Cleared
Dec 19, 1994
CORVAC PLASTIC BLOOD COLLECTION TUBE
Sherwood Medical Co.
Chemistry
81d
Cleared
May 02, 1994
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER
Sherwood Medical Co.
Chemistry
117d
Cleared
Feb 07, 1994
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
Organon Teknika Corp.
Microbiology
179d
Cleared
Oct 12, 1993
VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
92d
Cleared
Nov 16, 1992
MULTIDRAW SYSTEM
Cambridge Multi-Draw, Inc.
Chemistry
154d
Cleared
Jul 10, 1992
ANGEL WING SETS -- MODIFIED
Mbo Laboratories, Inc.
Chemistry
58d
Cleared
May 28, 1992
DIRECTDRAW SUPERSERUM
International Technidyne Corp.
Chemistry
44d
Cleared
Apr 29, 1992
VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
23d
Cleared
Feb 18, 1992
ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.
Mbo Laboratories, Inc.
Hematology
34d
Cleared
Jan 08, 1992
VACUTAINER KIT
Abbott Laboratories
Chemistry
68d
Cleared
Jan 08, 1992
CORVAC BLOOD COLLECTION TUBE
Sherwood Medical Co.
Chemistry
51d
Cleared
Feb 26, 1990
1400 SERIES EVIDENCE COLLECTION KIT
Transidyne General Corp.
Pathology
112d
Cleared
Jan 23, 1990
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
Radiometer America, Inc.
Chemistry
70d
Cleared
Jul 18, 1988
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
Terumo Medical Corp.
Hematology
31d
About Product Code GIM - Regulatory Context
510(k) Submission Activity
39 total 510(k) submissions under product code GIM since 1976, with 39 receiving FDA clearance (average review time: 91 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.