AccessGUDID - DEVICE: safePICO70 (05700699566102)

GUDID

Device Identifier (DI) Information

Brand Name: safePICO70
Version or Model: 956-610
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 956-610
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699566102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: safePICO without needle, Arterial blood sampler without needle, with vented TIPCAP, 1.5 mL, box of 100 pcs.

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

FDA Product Code

[?]

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

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: 59ee47b5-cc0e-49db-8ef7-6408a4e9d3c5
Public Version Date: July 02, 2024
Public Version Number: 5
DI Record Publish Date: September 01, 2016