Ultraview

GUDID 10841522105333

MDTM REC,DL,EN,UHF U

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver Electrocardiography monitoring system receiver

• Primary Device ID: 10841522105333
• NIH Device Record Key: 91c8696a-8c9e-4bef-8deb-9fc29834e22c
• Commercial Distribution Discontinuation: 2019-01-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ultraview
• Version Model Number: 90478
• Company DUNS: 145581588
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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 Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522105333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983996

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: 2
• Public Version Date: 2022-11-28
• Device Publish Date: 2019-01-23

On-Brand Devices [Ultraview]

• 10841522108662: TELEMETRY MODULE HSG, UHF/VHF, 115VAC, RFB
• 10841522127052: KIT, MULTI-BAND, WO/PS, PLEN, ACT ANT,ADC
• 10841522108648: MDTM REC, UHF 430-442, REFURBED
• 10841522108631: MDTM, UHF 614-620MHZ, REFURB
• 10841522108464: MDTM REC, UHF U, REFURB
• 10841522108426: R-90478, T-BAND UHF,602-608MHZ
• 10841522108402: MODULE, TELEMETRY,MVO,UHF 608-614MHZ
• 10841522105869: MDTM REC,FR,MVII,DL,UHF 430-442
• 10841522105661: MDTM,MV2,UHF 614-620MHZ
• 10841522105654: MDTM REC,MV2,DL,EN,UHF U
• 10841522105647: MDTM,MV2,UHF 602-608MHZ
• 10841522105630: MDTM,MV2,ST,UHF 614-620MHZ
• 10841522105623: MDTM,MV2,DL,ST,EN,UHF US
• 10841522105616: MDTM,MV2,ST,UHF 602-608MHZ
• 10841522105586: MDTM,RCVR,DL,MV2,ST,EN,614MHZ
• 10841522105579: MDTM,MV2,UHF 608-614 MHZ
• 10841522105500: MDTM,MV1,UHF 614-620MHZ
• 10841522105494: MDTM REC,MV1,DL,EN,UHF U
• 10841522105487: MDTM,MV1,UHF 602-608MHZ
• 10841522105470: MDTM,MV1,ST,UHF 614-620MHZ
• 10841522105463: MDTM, MV1, DL, ST, UHF
• 10841522105456: MDTM,MV1,ST,UHF 602-608MHZ
• 10841522105425: MDTM,MV1,ST,UHF 608-614MHZ
• 10841522105418: MDTM,MV1,UHF 608-614MHZ
• 10841522105340: MDTM,MV0,UHF 614-620MHZ
• 10841522105333: MDTM REC,DL,EN,UHF U
• 10841522105326: MDTM,MV0,UHF 602-608MHZ
• 10841522105302: MDTM,MV0,DL,ST,UHF US
• 10841522105296: MDTM,MV0,ST,UHF 602-608MHZ
• 10841522105265: MDTM,MVO,ST,UHF 608-614MHZ
• 10841522105258: MDTM,MVO,UHF 608-614MHZ
• 10841522105203: MDTM,MV0,DL,ST,G BAND
• 10841522102844: KIT,TM MOD,MV2 TO MV2 ST
• 10841522102837: KIT,TM MOD,MV1 ST TO MV2 ST
• 10841522102813: KIT,TM MOD,MV1 TO MV2
• 10841522102806: KIT,TM MOD,MV1 TO MV1 ST
• 10841522102790: KIT,TM MOD,MV0 ST TO MV2 ST
• 10841522102752: KIT,TM MOD,MV0 TO MV2 ST
• 10841522102745: KIT,TM MOD,MV0 TO MV2