AccessGUDID - DEVICE: TSCD®-II (05020583620032)

GUDID

Device Identifier (DI) Information

Brand Name: TSCD®-II
Version or Model: 62003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TERUMO BCT, INC.

Primary DI Number: 05020583620032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801679200 *Terms of Use

Device Description: Weld Integrity Test Kit for TSCD®II Sterile Tubing Welder

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?
36674	Package sealing unit	A mains electricity (AC-powered) device intended to be used for sealing packaged products and utensils, e.g., blood products, test tubes or sterilized instruments/equipment, through the application of heat upon the packaging materials to create an airtight seal. It is typically used in operating room (OR) departments, sterile packaging centres, and laboratories.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSB	SET, TRANSFER (BLOOD/PLASMA)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK860041	0

Device Exempt from Premarket Submission: No 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 20 and 25 Degrees Celsius
Special Storage Condition, Specify: Avoid Excessive Heat
Special Storage Condition, Specify: Avoid Freezing

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bde22bce-0d8d-4425-84f9-066bf3c53c08
Public Version Date: September 27, 2023
Public Version Number: 6
DI Record Publish Date: September 15, 2017

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)339-4228
Email: FDAUDIprogram@terumobct.com

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