AccessGUDID - DEVICE: QUANTIEN™ (05415067004635)

GUDID

Device Identifier (DI) Information

Brand Name: QUANTIEN™
Version or Model: Measurement System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C12797
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067004635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: No description.

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?
43621	Desk mount	A non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.	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 is package is damaged.
Handling Environment Temperature: between -20 and 70 Degrees Celsius
Handling Environment Temperature: between -4 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ca239d6-44c0-47c6-a4a0-8583dde27cfa
Public Version Date: March 29, 2018
Public Version Number: 2
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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