HeartStart M5530A

GUDID 00884838021945

Combiner plug for 3-wire lead set

Philips Medical Systems Hsg

Electrocardiographic lead set, reusable
Primary Device ID00884838021945
NIH Device Record Keyf3b8401a-c5a2-465c-92de-7c85d945eb26
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartStart
Version Model NumberCombiner Plug for 3-Wire Lead Set
Catalog NumberM5530A
Company DUNS790605856
Company NamePhilips Medical Systems Hsg
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838021945 [Primary]

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-03
Device Publish Date2024-09-25

Devices Manufactured by Philips Medical Systems Hsg

00884838094826 - Cardiac Workstation2025-02-03 Cardiac Workstation 5000
00884838094833 - Cardiac Workstation2025-02-03 Cardiac Workstation 7000
00884838127692 - Paper2025-01-13 Thermal paper for PageWriter, 8.5" x 11"sheet. Case of 1600 sheets (8 z-foldpads of 200 sheets ea). Red grid w/2.9" (7.3cm) head
00884838127708 - Paper2025-01-13 Thermal Paper for PageWriter, A4 size z-fold. Red grid w/6.7cm header. For PageWriter 200/i, 100 & XL cardiographs
20884838116447 - Paper2025-01-13 8.5"x11" Z-fold paper, no header Cardiograph thermal paper. Red Grid. 8.5x11" (216 mm x 279 mm). Pkg = 1 case = 8 packs = 1600 s
20884838116430 - Paper2024-12-26 Thermal Array Paper Chemical/thermal paper, 10 rolls/box, roll length = 98 ft. (29.9m), width = 1.97 in (50mm), weight = 2 lbs (
00884838009486 - Paper2024-12-19 Thermal Array Paper Chemical/thermal paper, 10 rolls/box, roll length = 98 ft. (29.9m), width = 1.97 in (50mm), weight = 2 lbs (
00884838123717 - Care Assist2024-12-05 Care Assist

Trademark Results [HeartStart]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEARTSTART
HEARTSTART
73609215 1454082 Live/Registered
LAERDAL MEDICAL CORPORATION
1986-07-14

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