FDA.reportPublic FDA data

safePICO

Primary DI
01860003561903
Brand
safePICO
Company
RADIOMETER AMERICA INC.
Model
616-KIT Box of 100
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.
Published
2020-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2
MEGSyringe, AntistickGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01860003561903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01860003561903018600035619031860003561903

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007360600support@radiometeramerica.com

Regulatory Flags#

DUNS number
086661485
Device count
1
DM exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
01860003561927safePICO623-KIT Box of 1002020-09-25
10860003561901Safe PICO Kit616-KIT Box of 1002021-02-17
10860003561925Safe PICO Kit623-KIT Box of 1002021-02-17
00860003561904Safe PICO Kit616-KIT2020-09-25
00860003561928safePICO623-KIT2020-09-25
00860003561942VKR-5VKR-52020-09-25
00860003561959VKR-7VKR-72020-09-25
00860003561966VK-CREAVK-CREA2020-09-25
00860003561935VK-3VK-32020-09-23

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Primary DI, Brand, Company table
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00840216124028LiteTouchAsp Global, LLCMEG2026-10-30
00840216124301LiteTouchAsp Global, LLCMEG2026-10-30
09347144010009Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
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06971564461696ITLJiangsu Caina Medical Co.,LtdJKA2026-09-30
06971564461702ITLJiangsu Caina Medical Co.,LtdJKA2026-09-30
00859776006033K-QUE-SAR-SHIPPERQuest DiagnosticsJKA2026-09-15
10197344216123MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-24
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21