AccessGUDID - DEVICE: Aquastat (30859809005027)

GUDID

Device Identifier (DI) Information

Brand Name: Aquastat
Version or Model: 2T0806-SP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2T0806-SP
Company Name: MRP, LLC

Primary DI Number: 30859809005027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 120
Labeler D-U-N-S® Number*: 604012703 *Terms of Use

Device Description: Pre-filled Flush Syringe with 0.9% NaCL (saline), 10mL, Sterile Fluid

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?
46309	Vascular catheter flush syringe	A sterile device consisting of a barrel (cylinder) with plunger intended to be used to wash the lumen of a vascular access catheter in situ with a rush of solution to maintain patency. It is prefilled with a saline or low-dose heparin solution, and is typically used when a patient has an intravenous (IV) access device in place. It is not intended for dry product reconstitution, for medication dilution, or where IV therapy with sodium chloride (NaCl) or heparin is indicated. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NGT	Saline, Vascular Access Flush

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
Handling Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 Milliliter

Device Record Status

Public Device Record Key: 7090660d-58dd-4139-b27f-147d1d5984ce
Public Version Date: May 31, 2019
Public Version Number: 1
DI Record Publish Date: May 23, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
40859809005024	4	30859809005027		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00859809005026 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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: 6158332633
Email: Customercare@aquabiliti.com

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