AccessGUDID - DEVICE: Segment Sampler (SEG) (19555240401332)

GUDID

Device Identifier (DI) Information

Brand Name: Segment Sampler (SEG)
Version or Model: A200200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A200200
Company Name: ITL ASIA PACIFIC SDN. BHD.

Primary DI Number: 19555240401332
Issuing Agency: GS1
Commercial Distribution End Date: March 11, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 597723837 *Terms of Use

Device Description: SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.

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):	Yes
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?
60210	Blood donor bag segment sampling IVD	A sampling device intended to be used for extracting a blood specimen from a blood donor bag tubing segment for analysis and/or other investigation (e.g., blood grouping, cross matching). It typically consists of a needle surrounded by plastic housing designed so that the blood-filled tubing segment may be inserted into the housing, pierced by the needle, and a sample manually extracted without exposing the user to either the blood or the needle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSS	Supplies, Blood-Bank

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK170102	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep Away from Direct Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2a6159a5-7a4a-4ea8-ab8f-0fd01b1b9665
Public Version Date: August 08, 2024
Public Version Number: 2
DI Record Publish Date: September 19, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
19555240401349	60	19555240401332	2024-03-11	Not in Commercial Distribution	Inner Box
19555240401356	6	19555240401349	2024-03-11	Not in Commercial Distribution	Carton