AccessGUDID - DEVICE: N/A (00817827025099)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: T3000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T3000
Company Name: CHARTER MEDICAL, LTD.

Primary DI Number: 00817827025099
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 029062325 *Terms of Use

Device Description: 150 mL Quad Aliquot Bag System

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?
46346	Paediatric blood donor set	A sterile assembly consisting of multiple collection containers (typically five connected flexible bags) of smaller volume than those used in adult sets. It is used for the storage of adult donor blood which is decanted from a normal adult size pack into this device in order to create smaller paediatric volume packs for infusion. The individual paediatric packs are then separated and sealed for later infusion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK960043	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4736595b-c36c-4892-83de-300919b470a9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 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
00817827025594	24	00817827025099		In Commercial Distribution

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (866) 458-3116
Email: CML_CustomerService@CharterMedical.com

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