AccessGUDID - DEVICE: Capre F5 AM (06430021930538)

GUDID

Device Identifier (DI) Information

Brand Name: Capre F5 AM
Version or Model: Capre F5 AM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Capre F5 AM
Company Name: Lojer Oy

Primary DI Number: 06430021930538
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 368184922 *Terms of Use

Device Description: Treatment table

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):	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?
31362	Examination/treatment table, line-powered	A mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INQ	Table, Powered

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 Temperature: between 10 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Atmospheric Pressure: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: Transport temperature - 10 to +40 °C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 297a18f1-562d-4e1d-97fc-9e1e4de101a9
Public Version Date: December 08, 2022
Public Version Number: 1
DI Record Publish Date: November 30, 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

[?]

Phone: +358108306700
Email: info@lojer.com

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