AccessGUDID - DEVICE: Innovo (00856298006060)

GUDID

Device Identifier (DI) Information

Brand Name: Innovo
Version or Model: Innovo
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101759
Company Name: SCOTTCARE CORPORATION, THE

Primary DI Number: 00856298006060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808204957 *Terms of Use

Device Description: Cardiac Rehab ECG telemetry transmitter.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
36367	Electrocardiography telemetric monitoring system transmitter	A body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin temperature, or haemoglobin oxygen saturation (SpO2)] to a remote receiver (e.g., central station server); it may in addition record/analyse data during a period of time for later retrieval (Holter reporting). The transmitter typically includes an antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, and may be provided with dedicated data management/communication software. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050778	000

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 10 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e9dca9d9-f8fd-4b22-8081-db33a67c3b62
Public Version Date: May 07, 2019
Public Version Number: 4
DI Record Publish Date: September 19, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 216-362-0550
Email: service@scottcare.com

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