AccessGUDID - DEVICE: TSCD (04987350726971)

GUDID

Device Identifier (DI) Information

Brand Name: TSCD
Version or Model: SC*W017
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TERUMO CORPORATION

Primary DI Number: 04987350726971
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 70
Labeler D-U-N-S® Number*: 690543319 *Terms of Use

Device Description: TSCD Wafers

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 [?]
Premarket Submission Number Not Available/Not Released

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 -10 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: non-condensing, This way up, Fragile, handle with care, Stacking limit by 10, Keep away from sunlight, Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 984d3f34-0fb1-4bd5-b897-0f6b39e47dcd
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 09, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
34987350726972	2	04987350726971		In Commercial Distribution
54987350726976	40	04987350726971		In Commercial Distribution

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 84987350726977 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

[?]

Phone: +1(303)205-2510
Email: FDAUDIprogram@terumobct.com

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