N/A

GUDID 00840682119832

GE Healthcare Finland Oy

Frame/rail/pole device holder

• Primary Device ID: 00840682119832
• NIH Device Record Key: b0e44e92-6d9c-4763-acdd-61a418ad9610
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: M1049197
• Company DUNS: 401966697
• Company Name: GE Healthcare Finland Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682119832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043551

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2017-04-11

On-Brand Devices [N/A]

• 00840682120104: M1051023
• 00840682120098: M1051025
• 00840682119832: M1049197
• 00840682137829: ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD W
• 00840682140799: ECG LEADWIRE SET, 5-LD, GRABBER, AHA, 74 CM/ 29 IN
• 00840682140522: ECG Leadwire set, 6-lead, grouped, grabber, AHA, 7
• 00840682140508: ECG Leadwire set, 3-lead, snap, IEC, 130 cm/ 51 in
• 00840682140478: ECG Leadwire set, 5-lead C2-6, snap, IEC, 130 cm/
• 00840682140461: ECG Leadwire set, 6-lead, grouped, grabber, AHA, 1
• 00840682140430: DIN Converter, 3-lead
• 00840682140409: ECG Leadwire set, 6-lead, grouped, snap, IEC, 130
• 00840682140393: ECG Leadwire set, 5-lead C2-6, snap, IEC, 74 cm/ 2
• 00840682140379: ECG Leadwire set, 6-lead, grouped, snap, IEC, 74 c
• 00840682140355: DIN Converter, 12-lead Kit
• 00840682140348: ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/
• 00840682140317: ECG Leadwire set, 3-lead, grabber, IEC, 130 cm/ 51
• 00840682140287: ECG Leadwire set, 5-lead V2-6, grabber, AHA, 130 c
• 00840682140256: ECG Leadwire set, 6-lead, grouped, grabber, IEC, 1
• 00840682140232: ECG Leadwire set, 3-lead, grabber, AHA, 130 cm/ 51
• 00840682140201: ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in
• 00840682140171: ECG Leadwire set, 5-lead, grouped, snap, IEC, 130
• 00840682140157: DIN Converter, 5-lead
• 00840682140133: ECG Leadwire set, 5-lead, grabber, IEC, mix 74 cm/
• 00840682140126: ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 c
• 00840682140119: ECG Leadwire set, 3-lead, snap, AHA, 130 cm/ 51 in
• 00840682140102: ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 2
• 00840682140096: ECG Leadwire set, 5-lead, grouped, snap, AHA, 130
• 00840682140089: ECG Leadwire set, 5-lead, grouped, grabber, IEC, 1
• 00840682140072: ECG Leadwire set, 6-lead, grouped, grabber, IEC, 7
• 00840682140058: ECG Leadwire set, 3-lead, grabber, IEC, 74 cm/ 29
• 00840682140041: ECG Leadwire set, 6-lead, grouped, grabber, AHA, m
• 00840682140034: ECG Leadwire set, 5-lead, grouped, snap, AHA, mix
• 00840682140003: ECG Leadwire set, 5-lead, grabber, IEC, 74 cm/ 29
• 00840682139984: ECG Leadwire set, 5-lead, grouped, grabber, IEC, m
• 00840682139960: ECG Leadwire set, 5-lead, grouped, grabber, AHA, 7
• 00840682139953: ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in
• 00840682139939: ECG Leadwire set, 5-lead, snap, IEC, 130 cm/ 51 in
• 00840682139922: ECG Leadwire set, 5-lead C2-6, grabber, IEC, 130 c
• 00840682139892: ECG Leadwire set, 5-lead V2-6, snap, AHA, 130 cm/
• 00840682139885: ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm
• 00840682139854: ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29
• 00840682139847: ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in
• 00840682139830: ECG Leadwire set, 5-lead, grabber, AHA, 130 cm/ 51
• 00840682139823: ECG Leadwire set, 5-lead C2-6, grabber, IEC, 74 cm
• 00840682139816: ECG Leadwire set, 5-lead, grouped, snap, IEC, mix
• 00840682139786: ECG Leadwire set, 5-lead, grouped, grabber, AHA, m
• 00840682139779: ECG Leadwire set, 5-lead, grouped, grabber, AHA, 1
• 00840682139724: ECG Leadwire set, 3-lead, snap, IEC, 74 cm/ 29 in
• 00840682139717: ECG Leadwire set, 6-lead, grouped, grabber, IEC, m
• 00840682139700: ECG Leadwire set, 5-lead, grouped, grabber, IEC, 7