No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08719481720964 | BPM-634s | Blood pressure monitor with a small cuff | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | iPovèn | |
2 | 08719481720957 | BPM-634 | Blood pressure monitor with a big cuff | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | iPovèn | |
3 | 08719481720063 | BPM-2244BT | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | iProvèn | ||
4 | 08719481720155 | DMT-316 | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | ||
5 | 08719481720070 | ET-828BT | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | ||
6 | 00871948172070 | BPM-337BT | Blood Pressure Monitor measuring around the wrist with Bluetooth | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | iProven | |
7 | 08719481720490 | BPM-2244BT-10 | Blood Pressure Monitor with Bluetooth 10 units in one carton | DXN | System, Measurement, Blood-Pressure, Non-Invasive | iProven | ||
8 | 08719481720117 | BBT-113A-W | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | ||
9 | 08719481720100 | DT-R1221A-W | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | ||
10 | 08719481720094 | BBT-113Ai | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | ||
11 | 08719481720087 | BBT-113A2 | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | ||
12 | 08719481721459 | DMT-489-new | Dual mode thermometer | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
13 | 08719481720148 | DMT-489-2 | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | ||
14 | 08719481721077 | FK-127s-A | Fertility KIT with 30 teststrips | LCX,NGE | Kit, Test, Pregnancy, Hcg, Over The Counter,Test, Luteinizing Hormone (Lh), Over Kit, Test, Pregnancy, Hcg, Over The Counter,Test, Luteinizing Hormone (Lh), Over The Counter | 1 | iProvèn | |
15 | 08719481720056 | DT-R1221B | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | ||
16 | 08719481720049 | DT-R1221A | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | ||
17 | 08719481721060 | FL-50-LH-A | Box with 35 ovulation teststrips | NGE | Test, Luteinizing Hormone (Lh), Over The Counter | iProvèn | ||
18 | 08719481721053 | FL-50-A | Box with 50 ovulation teststrips | NGE | Test, Luteinizing Hormone (Lh), Over The Counter | iProvèn | ||
19 | 08719481722395 | BBT-271B-22395 | Basal body thermometer Purple | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
20 | 08719481722388 | BBT-271A-22388 | Basal body thermometer Pink | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
21 | 08719481722173 | DTR-1221-US-P | Digital thermometer Pink color | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
22 | 08719481722166 | DTR-1221-US-BGW | Digital thermometer Back green white color | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
23 | 08719481722159 | DTR-1221-US-BG | Digital thermometer Black green color | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
24 | 08719481722142 | DTR-1221-US-BLU | Digital thermometer Blue color | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
25 | 08719481722067 | DMT-316b | Dual mode thermometer with white cap | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
26 | 08719481722043 | FMH-139-5 | Box with five midstream pregnancy tests | LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | iProvèn | ||
27 | 08719481722029 | FMH-139-3 | Box with three midstream pregnancy tests | LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | iProvèn | ||
28 | 08719481721695 | DT-R1221B-US-WG | Medical thermometer with rigid tip | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
29 | 08719481721671 | DT-R1221A-US-WG | Medical thermometer with flexible tip | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
30 | 08719481721657 | DT-K117B-US-WG | Medical thermometer with rigid tip | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
31 | 08719481721633 | DT-K117A-US-WG | Medical thermometer with flexible tip | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
32 | 08719481721619 | BBT-113i-US-WG | Basal body thermometer with backlight | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
33 | 08719481721596 | BBT-113Ai-US-WG | Basal body thermometer | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
34 | 08719481721541 | Oxi-27 | Oximeter | DQA | Oximeter | 2 | iProvèn | |
35 | 08719481721503 | TMT-215 | Triple mode thermometer with mute button | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
36 | 08719481721466 | DMT-316-new | Dual mode thermometer | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
37 | 08719481721022 | DMT-316w | Dual mode thermometer | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
38 | 08719481720865 | FK-127-A | Fertility KIT with 70 teststrips | NGE,LCX | Test, Luteinizing Hormone (Lh), Over The Counter,Kit, Test, Pregnancy, Hcg, Over Test, Luteinizing Hormone (Lh), Over The Counter,Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | iProvèn | |
39 | 08719481720803 | DMT-489g | Dual mode thermometer | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
40 | 08719481720780 | BPM-337BT-45 | Blood Pressure Monitors 45 units in one carton for measuring around the wrist wi Blood Pressure Monitors 45 units in one carton for measuring around the wrist with Bluetooth. | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | iProvèn | |
41 | 08719481720773 | FL-35 | Box with 35 ovulation teststrips | NGE | Test, Luteinizing Hormone (Lh), Over The Counter | iProvèn | ||
42 | 08719481720766 | FL-50 | Box with 50 ovulation teststrips | NGE | Test, Luteinizing Hormone (Lh), Over The Counter | iProvèn | ||
43 | 08719481720759 | FH-30 | Box with 30 pregnancy teststrips | JHI,LCX | Visual, Pregnancy Hcg, Prescription Use,Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | iProvèn | |
44 | 08719481720742 | BPM-2244sBT | Blood Pressure Monitor with standard cuff with Bluetooth | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | iProvèn | |
45 | 08719481720728 | FK-127s | Box with 25 ovulation teststrips and 5 pregnancy teststrips | LCX,JHI | Kit, Test, Pregnancy, Hcg, Over The Counter,Visual, Pregnancy Hcg, Prescription Use | 2 | iProvèn | |
46 | 08719481720711 | BPM-337-45 | Blood Pressure Monitors 45 units in one carton for measuring around the wrist. | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | iProvèn | |
47 | 08719481720704 | BPM-337BT | Blood Pressure Monitor measuring around the wrist with Bluetooth | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | iProvèn | |
48 | 08719481720681 | BPM-337 | Blood Pressure Monitor measuring around the wrist | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | iProvèn | |
49 | 08719481720209 | BBT-113i | digital thermometer to measure basal body temperature | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn | |
50 | 08719481720193 | ET-624BT | Ear thermometer with bluetooth which transmits data to app on mobile phone | FLL | Thermometer, Electronic, Clinical | 2 | iProvèn |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M901W1C0 | W1-C | W1-C | immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG) | QuickProfile™ HCG Test Card | LUMIQUICK DIAGNOSTICS, INC. |
2 | 20888277703572 | MPH12325HCG | MPH12325HCG | TEST,HCG,PREGNANCY,URINE,CASS,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
3 | 20888277703565 | MPH11325HCG | MPH11325HCG | TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
4 | M752682PREG1 | 682-PREG | Pregnancy Kits | Stradis Medical, LLC | STRADIS MEDICAL, LLC | |
5 | 10817038021887 | U-HCG-102 | U-HCG-102 | UCP Home Pregnancy Test Cassette | UCP Home Pregnancy Test Cassette | UCP BIOSCIENCES, INC. |
6 | 10817038021269 | U-HCG-101 | U-HCG-101 | UCP HOME Pregnancy Test Strip | UCP Home | UCP BIOSCIENCES, INC. |
7 | 10817038021214 | hCG strip | hCG strip | UCP HOME Pregnancy Test Strip | UCP HOME | UCP BIOSCIENCES, INC. |
8 | 10817038021023 | UCD-Preg-CLIA | UCD-Preg-CLIA | Pregnancy Dip Card | UCP Home Pregnancy Dip Card | UCP BIOSCIENCES, INC. |
9 | 10796918002140 | 02-2480-2 | HCG Midstream Cassette, 2 tests | Instant-View HCG Midstream Cassette, 2t | ALFA SCIENTIFIC DESIGNS, INC. | |
10 | 10722355002887 | IDP-25 | Home pregnancy test for early results | Detector hCG Personal | IMMUNOSTICS COMPANY, INC | |
11 | 10722355001453 | IDP-3 | Home pregnancy test for early results | Detector Personal | IMMUNOSTICS COMPANY, INC | |
12 | 10722355001392 | IDP-100 | For the qualitative detection of hCG in urine | Detector hCG Personal | IMMUNOSTICS COMPANY, INC | |
13 | 10722066005146 | HCG-1C50 | HCG-1C50 | Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitat Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitative detection of human chorionic gonadotropin in urine. | Rapid Response | BTNX INC |
14 | 09351337000081 | GM-700O | Ovulation test | GENERATION GUARD PTY LTD | ||
15 | 09351337000074 | GM-700P | Pregnancy test | GENERATION GUARD PTY LTD | ||
16 | 09351337000029 | GM-700PO | Ovulation and Pregnancy test Kit | GENERATION GUARD PTY LTD | ||
17 | 08809408860597 | HCGS003E | Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the s Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use. | Surearly™ Pregnancy Test Strip | SUGENTECH INC._OSONG BRANCH | |
18 | 08809408860191 | SU-DR02-CG | HCGR001E | Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, co Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display. | Surearly™ Digital Pregnancy Test | SUGENTECH INC._OSONG BRANCH |
19 | 08719699634633 | FK-127-CO | FK-127A contains 50 ovulation test and 20 pregnancy tests. | iProven | SEVENGROUND TRADING B.V. | |
20 | 08719699633254 | FMH-139-3 | FMH-139 is a One Step HCG Urine Pregnancy Test | iProven | SEVENGROUND TRADING B.V. | |
21 | 08719699633230 | FMH-139-5 | FMH-139 is a One Step HCG Urine Pregnancy Test | iProven | SEVENGROUND TRADING B.V. | |
22 | 08719699630901 | FMH-139-5 | FMH-139 is a One Step HCG Urine Pregnancy Test | iProven | SEVENGROUND TRADING B.V. | |
23 | 08719481722043 | FMH-139-5 | Box with five midstream pregnancy tests | iProvèn | MASENA INVEST B.V. | |
24 | 08719481722029 | FMH-139-3 | Box with three midstream pregnancy tests | iProvèn | MASENA INVEST B.V. | |
25 | 08719481721077 | FK-127s-A | Fertility KIT with 30 teststrips | iProvèn | MASENA INVEST B.V. | |
26 | 08719481721046 | FH-30-HCG-A | Box with 30 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
27 | 08719481720865 | FK-127-A | Fertility KIT with 70 teststrips | iProvèn | MASENA INVEST B.V. | |
28 | 08719481720759 | FH-30 | Box with 30 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
29 | 08719481720728 | FK-127s | Box with 25 ovulation teststrips and 5 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
30 | 08719481720179 | FK-127-W-HCGtest | HCG strips - pregnancy test strips - REGISTRATION NUMBER HCG STRIP: 21 CFR 862.1155 | iProvèn | MASENA INVEST B.V. | |
31 | 08719481720162 | FK-127-HCGtest | HCG strips - pregnancy test strips | iProvèn | MASENA INVEST B.V. | |
32 | 07350014630209 | 20 | Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermomet Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation strip tests and 5 pregnancy strip tests. | Natural Cycles | NATURALCYCLES NORDIC AB | |
33 | 07350014630155 | 15 | Test, Pregnancy, Hcg, Over The Counter | Natural Cycles | NATURALCYCLES NORDIC AB | |
34 | 06974464590084 | 0741M4X003 | One Step HCG Urine Test Midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
35 | 06974464590053 | 0741M4X002 | LH and HCG combo test midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
36 | 06974464590046 | 0741M4X005 | LH and HCG combo test midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
37 | 06974464590039 | 0731S3X020 | LH and HCG combo test strip | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
38 | 06970429840300 | HCG Cassette | Co-innovation | CO-INNOVATION BIOTECH CO., LTD | ||
39 | 06970429840164 | 1 | HCG TEST | PREGABLE | CO-INNOVATION BIOTECH CO., LTD | |
40 | 06970429840157 | HCG3.5 | HCG TEST STRIP | CO-INNOVATION BIOTECH CO., LTD | ||
41 | 06970429840133 | HCG Test Strip | HealthyWiser | CO-INNOVATION BIOTECH CO., LTD | ||
42 | 06970429840126 | HCG Pregnancy Test | HCG Pregnancy Test Strip | AICARE | CO-INNOVATION BIOTECH CO., LTD | |
43 | 06970429840119 | HCG TEST STRIP | HCG TEST STRIP | MomMed | CO-INNOVATION BIOTECH CO., LTD | |
44 | 06970429840102 | HCG Strip/4.0mm | Co-innovation | CO-INNOVATION BIOTECH CO., LTD | ||
45 | 06970277512404 | FHC-103H | FHC-103H | Pregnancy (hCG) Rapid Test Midstream | Pregnancy (hCG) Rapid Test Midstream | HANGZHOU ALLTEST BIOTECH CO., LTD. |
46 | 06942820412332 | HCG (2.0) | One Step HCG Urine Pregnancy Test Strip | ChoiceMMed | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. | |
47 | 06938444985017 | 11C-1867-U | RH-HCG-B | LotFancy Pregnancy Test is a self-testing immunoassay designed for the qualitati LotFancy Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 25pcs of 2.5mm strips in each box. | LotFancy | RUNBIO BIOTECH CO., LTD. |
48 | 06938444982641 | 82641 | DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, 10 pregnancy test strips and 2 pregnancy crystal tests. | DAVID | RUNBIO BIOTECH CO., LTD. | |
49 | 06938444982610 | 82610 | DAVID Pregnancy Test is intended for the qualitative determination of human chor DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 6 ctrystal strips and 10 regular strips in one box.. | DAVID | RUNBIO BIOTECH CO., LTD. | |
50 | 06938444982603 | 82603 | DAVID Ovulation & Pregnancy Test is consisiting of 90 ovulation test strips and DAVID Ovulation & Pregnancy Test is consisiting of 90 ovulation test strips and 30 pregnancy test strips . | DAVID | RUNBIO BIOTECH CO., LTD. |