AccessGUDID - DEVICE: Clot catcher (05700699060204)

GUDID

Device Identifier (DI) Information

Brand Name: Clot catcher
Version or Model: 906-020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 906-020
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699060204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: Clot catcher, box of 250 pcs. for ABL7XX

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?
66079	Analyser blood clot protection filter IVD	A screening device intended to be placed in a blood specimen receptacle (e.g., capillary blood collection tube) prior to loading it into an in vitro diagnostic analyser (e.g., blood gas analyser) to trap blood clots and prevent them from entering the analyser. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CGA	GLUCOSE OXIDASE, GLUCOSE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
GKF	INSTRUMENT, HEMATOCRIT, AUTOMATED
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
JJS	CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
KHP	ACID, LACTIC, ENZYMATIC METHOD
CIG	DIAZO COLORIMETRY, BILIRUBIN
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bca4988a-32e3-405b-b90a-c068f2518ae9
Public Version Date: July 02, 2024
Public Version Number: 4
DI Record Publish Date: September 01, 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: 55700699060209 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +459999999999
Email: radiometer@radiometer.dk

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