AccessGUDID - DEVICE: Alinity (00380740132538)

GUDID

Device Identifier (DI) Information

Brand Name: Alinity
Version or Model: 09P8201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09P8201
Company Name: Abbott GmbH

Primary DI Number: 00380740132538
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315786293 *Terms of Use

Device Description: Alinity h-series Slide Label Cartridge

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:	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?
62926	Microscope slide labelling cartridge IVD	A device designed to be inserted into an automated microscope slide processing instrument (e.g., printer, stainer, or maker) to label a microscope slide for specimen identification prior to blood smearing. It is a casing, similar to a paper printer cartridge, with a printer ribbon that makes thermal contact with the slide, with heat and printed data from the processing instrument, to transfer information to the slide.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPA	Slide stainer, automated

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 975c5b64-5c09-4aa1-87b2-4f02cfe4579f
Public Version Date: November 24, 2023
Public Version Number: 1
DI Record Publish Date: November 16, 2023

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

Customer Contact

[?]

Phone: +1(877)422-2688
Email: xx@xx.xx

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