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
39 devices
Cleared
Jun 29, 1977
BLOOD COLLECTION TUBE, BLUE
Sherwood Medical Industries
Chemistry
16d
Cleared
Jun 29, 1977
BLOOD COLLECTION TUBE, RED
Sherwood Medical Industries
Chemistry
16d
Cleared
Jun 29, 1977
BLOOD COLLECTION TUBE, GREEN
Sherwood Medical Industries
Chemistry
16d
Cleared
Jun 27, 1977
BLOOD COLLECTION TUBE, LAVENDER
Sherwood Medical Industries
Chemistry
14d
Cleared
Jul 20, 1976
VACUUM TUBES, STERILE (J-VAC)
Jelco Laboratories
Hematology
39d
Cleared
Jul 20, 1976
VACUUM TUBES, PEDIATRIC SIZES (J-VAC)
Jelco Laboratories
Hematology
39d