AccessGUDID - DEVICE: i-STAT (00054749001385)

GUDID

Device Identifier (DI) Information

Brand Name: i-STAT
Version or Model: 06F24-16
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 06F24-16
Company Name: ABBOTT POINT OF CARE INC.

Primary DI Number: 00054749001385
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2023
Device Count: 500
Labeler D-U-N-S® Number*: 079226216 *Terms of Use

Device Description: IST DISPENSING TIP

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58146	Blood/blood culture specimen transfer spike IVD, manual	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRC	Micro Pipette

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c45c979d-efa5-40da-8f3f-3f4d2ab0449e
Public Version Date: June 09, 2025
Public Version Number: 3
DI Record Publish Date: June 23, 2023