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The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution
- 08806094948240 ()
- Self-care monitoring/reporting software
The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution
- 08806094948233 ()
- Self-care monitoring/reporting software
Sliding Safety Insulin Syringe with Needle, 1/2 cc, 29G x 1/2 in
MCKESSON MEDICAL-SURGICAL INC.
16-SN05C2905S
In Commercial Distribution
- 20612479268740 ()
- 10612479268736 ()
- 40612479268751 ()
- Insulin syringe/needle, safety
Curaplex Epi Kit incl 1 cc Syringe w/25 ga x 1 in Needle
BOUND TREE MEDICAL, LLC
680154-KIT
In Commercial Distribution
- 00817617020389 ()
- 00810094571894 ()
680154-KIT
- Adhesive bandage
- Antiseptic skin towelette
resorbable porous calcium phosphate bone void filler 25 x 100 x 8mm; 20 cc
Pioneer Surgical Technology, Inc.
90-400-251008
Not in Commercial Distribution
- 00846468087128 ()
90-400-251008
- Bone matrix implant, composite
resorbable porous calcium phosphate bone void filler 25 x 50 x 8mm; 10 cc
Pioneer Surgical Technology, Inc.
90-400-25508
Not in Commercial Distribution
- 00846468087111 ()
90-400-25508
- Bone matrix implant, composite
resorbable porous calcium phosphate bone void filler 25 x 50 x 4mm; 5 cc
Pioneer Surgical Technology, Inc.
90-400-25504
Not in Commercial Distribution
- 00846468087104 ()
90-400-25504
- Bone matrix implant, composite
Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100
Natus Medical Denmark ApS
1012 OTOflex Cavity set
In Commercial Distribution
- 05713315009013 ()
8-67-41300
- Impedance audiometer
SILICONE ELASTOMER COATED LATEX T.U.R.P. FOLEY CATHETER, 30-50 CC, 2-WAY, 24 FR (8.0 MM)
Cardinal Health 200, LLC
8887648247
In Commercial Distribution
- 20192253058427 ()
- 10192253058420 ()
- 50192253058428 ()
8887648247
- Indwelling urethral drainage balloon catheter, non-antimicrobial
HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY
Cardinal Health 200, LLC
3044
In Commercial Distribution
- 50192253027776 ()
- 10192253027778 ()
- Total Volume: 5 Milliliter
- Catheter Gauge: 18 French
3044-
- Indwelling urethral catheterization kit, adult