R MEDICAL SUPPLY INC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (2) Tube, Aspirating, Flexible, Connecting (BYY) (1)

Premarket Exempt

No Yes

Clear

R Med Collection Set - B49746721COLLSE0 Catalog Number :

Device Description : Vacuum Tubing with handle and adapter; single use, sterile, flexible, 6' long, 1 Vacuum Tubing with handle and adapter; single use, sterile, flexible, 6' long, 1/2" outer diameter.

Device Class : 2

Duns Number: 788124873

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : Yes

Device Count : 1

R Med Pregnancy Test Cassettes - B497542100C1001CA1 Catalog Number :

Device Description : Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual tests in pouches; 50 tests per box. Market--physician office.

Device Class :

Duns Number: 788124873

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

R Med Pregnancy Test Strip - B497542100C1001S1 Catalog Number :

Device Description : Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual test strips in pouches; 50 tests per box. Market--physician office

Device Class :

Duns Number: 788124873

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

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