FDA.reportPublic FDA data

i-STAT

Primary DI
00054749004027
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
06F24-20
Catalog number
06F24-20
Device description
Dispensing Tip, 100 Pack
Published
2023-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JRCMicro Pipette

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRCMicro PipetteClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749004027PrimaryGS10
10054749004024Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749004027000547490040270547490040270054749004027
1005474900402410054749004024

GMDN Terms#

Term, Definition table
TermDefinition
Blood/blood culture specimen transfer spike IVD, manualA hand-held manual device intended to be used to obtain a specimen of blood, blood components (e.g., platelets), or blood culture from a specimen receptacle, and facilitate its transfer to another receptacle [e.g., evacuated blood collection tube] for subsequent analysis. It consists of a spike/needle for sampling the specimen through the sealed stopper of the receptacle (i.e., without opening the receptacle), and is designed to reduce the risk of user exposure to the specimen and spike/needle [e.g., has a plastic housing for guarding the needle]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)366-8020techsvc@apoc.abbott.com

Regulatory Flags#

DUNS number
079226216
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10054749005519i-STAT09P31-2609P31-262020-05-01
10054749000163i-STAT03P88-2503P88-252016-09-09
10054749000132i-STAT03P85-2503P85-252016-09-09
00054749001385i-STAT06F24-1606F24-162023-06-23
00054749004911i-STAT hs-TnI Calibration Verification, Levels 1-306P17-2006P17-202025-05-02
00054749004928i-STAT hs-TnI Control Level 106P17-2106P17-212025-05-02
00054749004935i-STAT hs-TnI Control Level 206P17-2206P17-222025-05-02
00054749004942i-STAT hs-TnI Control Level 306P17-2306P17-232025-05-02
10054749003058i-STAT hs-TnI cartridge09P81-2509P81-252025-04-29
00054749003051i-STAT hs-TnI cartridge09P81-2509P81-252025-04-29
10054749005779i-STAT TBI cartridge03S09-2503S09-252024-07-08
00054749005772i-STAT TBI cartridge03S09-2503S09-252024-07-08
00054749000661i-STAT06F14-0106F14-012023-06-23
10054749000071i-STAT03P79-2503P79-252016-09-09
10054749000149i-STAT03P86-2503P86-252016-09-09
10054749000170i-STAT03P89-2403P89-242016-09-09
10054749000187i-STAT03P90-2503P90-252016-09-09
10054749000200i-STAT03P92-2503P92-252016-09-09
10054749000217i-STAT03P93-2503P93-252016-09-09
10054749000118i-STAT03P83-2503P83-252016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197007459cobas® Liat Transfer Pipette PackRoche Molecular Systems, Inc.JRC2026-03-26
10810050855799SmearsafeTYPENEX MEDICAL LLCJRC2025-10-13
04038917085830Haemo-Diff®Sarstedt Aktiengesellschaft & Co.KGJRC2025-09-25
00840095688840Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688857Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688864Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688871Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688888Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688895Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688901Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688918Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688925Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688932Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688949Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688956Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688994Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689007Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689014Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689021Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689038Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689045Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689052Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689069Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689076Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689083Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689090Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689106Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689113Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689120Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689137Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07