AccessGUDID - DEVICE: ImagineMIC (B353IM11101)

GUDID

Device Identifier (DI) Information

Brand Name: ImagineMIC
Version or Model: IM1110
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Lifesignals, Inc.

Primary DI Number: B353IM11101
Issuing Agency: HIBCC
Commercial Distribution End Date: April 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 798830720 *Terms of Use

Device Description: Biosensor Patch - Electrocardiography Telemetric Monitoring Patch

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):	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?
31733	Electrocardiography telemetric monitoring system	An assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency
DRX	Electrode, Electrocardiograph
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172011	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 Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Special Storage Condition, Specify: For Long-term storage of more than 30 days, maintain between 5 and 27 Degree Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 914bd733-5e6b-4058-87ff-0175fde7cd24
Public Version Date: April 13, 2022
Public Version Number: 3
DI Record Publish Date: May 06, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B353IM11103	8	B353IM11102	2021-04-30	Not in Commercial Distribution	Large Box
B353IM11102	25	B353IM11101	2021-04-30	Not in Commercial Distribution	BOX

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: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 510.770.6412
Email: saravanan@lifesignals.com

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