FDA.reportPublic FDA data

safePICO

Primary DI
00860003561928
Brand
safePICO
Company
RADIOMETER AMERICA INC.
Model
623-KIT
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 25Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL.
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00860003561928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003561928008600035619288600035619280860003561928

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
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
01860003561903safePICO616-KIT Box of 1002020-09-25
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
00860003561942VKR-5VKR-52020-09-25
00860003561959VKR-7VKR-72020-09-25
00860003561966VK-CREAVK-CREA2020-09-25
00860003561935VK-3VK-32020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613703130501VanishPoint®RETRACTABLE TECHNOLOGIES, INC.MEG2026-11-02
00840216123779LiteTouchAsp Global, LLCMEG2026-10-30
00840216123809LiteTouchAsp Global, LLCMEG2026-10-30
00840216123960LiteTouchAsp Global, LLCMEG2026-10-30
00840216123984LiteTouchAsp Global, LLCMEG2026-10-30
00840216124004LiteTouchAsp Global, LLCMEG2026-10-30
00840216124028LiteTouchAsp Global, LLCMEG2026-10-30
00840216124301LiteTouchAsp Global, LLCMEG2026-10-30
09347144010009Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010030Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010092Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010122Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
B098AMS188470Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188480Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188490Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188500Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188510Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188520Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288557McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288588McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
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