AccessGUDID - DEVICE: Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets (20884838114030)

GUDID

Device Identifier (DI) Information

Brand Name: Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets
Version or Model: 5 lead set Disp., Telemetry, AAMI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803173151
Company Name: Philips Medical Systems Hsg

Primary DI Number: 20884838114030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: 5-Lead Set, disposable, for single patient use, with protective shield, to measure ECG on IntelliVue Telemetry. AAMI color coded grabbers. Round (rd) peelable ribbon style wires. Wire length: 2,8 ft (85 cm). Connects directly to Patient Worn Device 862231 TRx4851A, 862439 TRx4841A, 862108 M2601B Transmitter. 1 Sales Unit = 20 single wrapped lead sets

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61821	Electrocardiographic lead set, single-use	A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 10 and 108 KiloPascal
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e081b1eb-8af6-4610-8c08-06dfe1ed6675
Public Version Date: September 24, 2024
Public Version Number: 1
DI Record Publish Date: September 16, 2024