AccessGUDID - DEVICE: UF ll CALIBRATOR (04987562408535)

GUDID

Device Identifier (DI) Information

Brand Name: UF ll CALIBRATOR
Version or Model: 06404310
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYSMEX CORPORATION

Primary DI Number: 04987562408535
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 690664461 *Terms of Use

Device Description: UF ll CALIBRATOR

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?
42064	Urine sediment IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIW	CALIBRATOR, SURROGATE

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
Storage Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 130ea8b5-88a5-469f-b916-746a924858fd
Public Version Date: November 07, 2022
Public Version Number: 6
DI Record Publish Date: October 06, 2017

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: 84987562408531 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: +1(888)879-7639
Email: crc@sysmex.com

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