Ultraview

GUDID 10841522105333

MDTM REC,DL,EN,UHF U

SPACELABS HEALTHCARE (WASHINGTON), INC

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
• 10841522108846: MULTIGAS MODULE, 92518, REFURB