Safe PICO Kit

GUDID 00860003561904

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

RADIOMETER AMERICA INC.

Arterial blood sampling kit

• Primary Device ID: 00860003561904
• NIH Device Record Key: bca6a629-14b8-4337-8762-7238a4bb5ac6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safe PICO Kit
• Version Model Number: 616-KIT
• Company DUNS: 086661485
• Company Name: RADIOMETER AMERICA INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com
• Phone: 8007360600
• Email: support@radiometeramerica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003561904 [Primary]

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [Safe PICO Kit]

• 00860003561904: 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 saf
• 10860003561925: 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 saf
• 10860003561901: 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 saf