AccessGUDID - DEVICE: Disposable Waste Container D512 REF 905-590 (05700699055903)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Waste Container D512 REF 905-590
Version or Model: 905-590
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 905-590
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699055903
Issuing Agency: GS1
Commercial Distribution End Date: August 27, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: D512 Disposable waste container 600mL 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?
62172	Laboratory waste receptacle IVD	A non-sterile container intended to collect and contain disposable materials/devices that have been contaminated due to contact with bodily fluids/substances (e.g., blood, sputum, urine, faeces) resulting from in vitro diagnostic procedures. It is typically in the form of a sack, box, or bottle made of durable plastic impervious to microorganisms. It may be used to collect solid and/or liquid waste from a laboratory instrument or analyser. This is a single-use device intended to be disposed of with its contents.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGA	GLUCOSE OXIDASE, GLUCOSE
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
JGS	ELECTRODE, ION SPECIFIC, SODIUM
KHP	ACID, LACTIC, ENZYMATIC METHOD
CHL	Electrode measurement, blood-gases (pco2, po2) and blood ph
JJS	Controls for blood-gases, (assayed and unassayed)
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CIG	DIAZO COLORIMETRY, BILIRUBIN
GKF	Instrument, hematocrit, automated

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
Special Storage Condition, Specify: Warning biological hazard Single use

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1a108127-6f43-4fc7-baa2-0755b41913b6
Public Version Date: August 28, 2024
Public Version Number: 4
DI Record Publish Date: September 21, 2018