AccessGUDID - DEVICE: Safe PICO Kit (10860003561901)

GUDID

Device Identifier (DI) Information

Brand Name: Safe PICO Kit
Version or Model: 616-KIT Box of 100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RADIOMETER AMERICA INC.

Primary DI Number: 10860003561901
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086661485 *Terms of Use

Device Description: 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd) Arterial blood sampler with 23Gx16mm needle, with needle shield device (nsd) and 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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
31336	Arterial blood sampling kit	A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. 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: 7381c41a-3db1-4bb1-82b1-37f04a3045c6
Public Version Date: February 25, 2021
Public Version Number: 1
DI Record Publish Date: February 17, 2021