safePICO

GUDID 00860003561928

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 25Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL.

RADIOMETER AMERICA INC.

Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit Arterial blood sampling kit
Primary Device ID00860003561928
NIH Device Record Key652fdb42-d88b-4fec-8f31-350a5d3f4e97
Commercial Distribution StatusIn Commercial Distribution
Brand NamesafePICO
Version Model Number623-KIT
Company DUNS086661485
Company NameRADIOMETER AMERICA INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com
Phone8007360600
Emailsupport@radiometeramerica.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003561928 [Primary]

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-05
Device Publish Date2020-09-25

On-Brand Devices [safePICO]

018600035619271-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 saf
018600035619031-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 saf
008600035619281-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 saf

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