AccessGUDID - DEVICE: Maquet Equipment (03700712411886)

GUDID

Device Identifier (DI) Information

Brand Name: Maquet Equipment
Version or Model: ARDSAT239008A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MAQUET SAS

Primary DI Number: 03700712411886
Issuing Agency: GS1
Commercial Distribution End Date: June 13, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 264700139 *Terms of Use

Device Description: EQTMHS013 SAT13

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:	No
Prescription Use (Rx):	No
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
FXR	Holder, Camera, Surgical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Handling Environment Humidity: between 20 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 20 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 21cc098a-a5a5-4b71-871b-991a1ff0b75e
Public Version Date: January 06, 2025
Public Version Number: 3
DI Record Publish Date: March 25, 2022

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

[?]

No Customer Contact currently defined

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