FDA.reportPublic FDA data

safePICO

Primary DI
05700699566232
Brand
safePICO
Company
Radiometer Medical ApS
Model
956-623
Catalog number
956-623
Device description
safePICO 25Gx16mm (nsd) Arterial blood sampler with 25Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL, box of 100 pcs.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700699566232PrimaryGS10
55700699566237Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699566232057006995662325700699566232
5570069956623755700699566237

GMDN Terms#

Term, Definition table
TermDefinition
Arterial blood sampling kitA 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.

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
+459999999999radiometer@radiometer.dk

Regulatory Flags#

DUNS number
308667539
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700693918808TCM 4 series ETX base unit391-880391-8802025-04-23
55700699428986SAFE CLINITUBES D957P-70-70X1942-898942-8982024-07-01
05700699460509SC90 50 BG, LYT, MET, OXI + QC946-050946-0502024-07-01
55700699428764CLINITUBES D941G-NA-240-85X10942-876942-8762022-12-08
55700699044391CAPILLARY CAPS, RED 160pcs.904-439904-4392022-12-05
55700699044537CAPILLARY CAPS, green 110pcs.904-453904-4532022-12-05
55700699056615CLINITUBES D956G-70-35*1905-661905-6612022-12-05
55700699060223ABL77 CAPILLARY ADAPTERS906-022906-0222022-12-05
05700699339393AQURE NT Premium933-939933-9392022-12-05
05700699339409AQURE NT Plus933-940933-9402022-12-05
55700699428696CLINITUBES D957G-70-35X5942-869942-8692022-12-05
55700699428757CLINITUBES D941G-240-85X5942-875942-8752022-12-05
55700699428788CLINITUBES D957G-70-100X5942-878942-8782022-12-05
55700699428825CLINITUBES D941G-80-140X5942-882942-8822022-12-05
55700699428849CLINITUBES D957G-70-210X5942-884942-8842022-12-05
55700699428856D941G-240-55X5942-885942-8852022-12-05
55700699428894SafeClinitube D941P-NA-240-55942-889942-8892022-12-05
55700699428900SAFE CLINIT. D941P-240-85X1942-890942-8902022-12-05
55700699428917SAFE CLINIT. D941P-NA-240-85X3942-891942-8912022-12-05
55700699428924SAFE CLINIT. D957P-70-100X1942-892942-8922022-12-05

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