AccessGUDID - DEVICE: PICO50 (05700699565525)

GUDID

Device Identifier (DI) Information

Brand Name: PICO50
Version or Model: 956-552
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 956-552
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699565525
Issuing Agency: GS1
Commercial Distribution End Date: October 11, 2022
Device Count: 100
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: PICO50 Arterial blood sampler, 2 mL, box of 100 units

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?
45267	Blood gas syringe IVD, sodium heparin	A sterile glass or plastic syringe, without a pre-attached needle, containing the anticoagulant sodium heparin intended to be used for the collection, and preservation and/or transport, of blood for blood gas determination and/or other investigation. This is a single-use device.	Active	false
57894	Blood gas syringe IVD, lithium heparin	A sterile glass or plastic syringe, without a pre-attached needle, containing the anticoagulant lithium heparin intended to be used for the collection, and preservation and/or transport, of blood for blood gas determination and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, vials, systems, serum separators, blood collection

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f8376c5-e2ad-4cb6-a9a4-d56433591cea
Public Version Date: November 01, 2022
Public Version Number: 3
DI Record Publish Date: September 01, 2016