AccessGUDID - DEVICE: QUANTIEN™ (05415067004642)

GUDID

Device Identifier (DI) Information

Brand Name: QUANTIEN™
Version or Model: C12798
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C12798
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067004642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Mounting Bracket

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":	No
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?
32245	Medical monitor/light mount	A permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSK	COMPUTER, BLOOD-PRESSURE
DQK	COMPUTER, DIAGNOSTIC, PROGRAMMABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Keep dry. Do not use if the package is damaged.
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit
Handling Environment Temperature: between -4 and 158 Degrees Fahrenheit
Handling Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c2dff5c-216a-4652-a71f-8971c2848cd8
Public Version Date: August 07, 2023
Public Version Number: 3
DI Record Publish Date: January 14, 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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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