AccessGUDID - DEVICE: Therapak (07312058462666)

GUDID

Device Identifier (DI) Information

Brand Name: Therapak
Version or Model: ACSK38107
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ACSK38107
Company Name: Therapak LLC

Primary DI Number: 07312058462666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791071165 *Terms of Use

Device Description: Generic Blood Alcohol Collection and Transport Kit (CS/24)

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:	Yes
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?
65859	Capillary blood collection set, professional	A collection of devices intended to be used by a healthcare professional at the point-of-care to collect a capillary blood sample from a patient for subsequent diagnostic testing or screening purposes. It typically includes a lancet and a blood collection device (consisting of a capillary tube and blood collection tube) and may also include gloves, gauze pads, alcohol pads and dressings. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KST	System, Blood Collection, Vacuum-Assisted, Manual

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fcf2db43-16e0-4125-86bb-f74c50ea1673
Public Version Date: June 09, 2025
Public Version Number: 2
DI Record Publish Date: December 21, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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