AccessGUDID - DEVICE: MD Resource (00859898006188)

GUDID

Device Identifier (DI) Information

Brand Name: MD Resource
Version or Model: ITD-Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ITD-Y
Company Name: MEDICAL DEVICE RESOURCE CORPORATION

Primary DI Number: 00859898006188
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 126830020 *Terms of Use

Device Description: ITD-Y - Infiltration Disposable 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":	Yes
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?
48138	Dual spike connector	A sterile device designed with two separate spikes intended to connect (spike) two separate saline bags for simultaneous connection to a parent device. It typically consists of polyvinyl chloride (PVC) Y-shaped tubing with spikes at the proximal end and manually-operated clamps on both branches of the Y-piece and a connector at the distal end. It is typically used by hospital staff during a wound debridement process. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGZ	Accessories, Catheter

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: 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: 71cbe803-83c6-4c59-894f-5088d2f47b47
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 31, 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
00859898006201	6	00859898006195		In Commercial Distribution
00859898006195	10	00859898006188		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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 510-732-9950
Email: sales@mdresource.com

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