AccessGUDID - DEVICE: Praxiject™ 0.9% NaCl (10682686004489)

GUDID

Device Identifier (DI) Information

Brand Name: Praxiject™ 0.9% NaCl
Version or Model: 37043US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 37043US
Company Name: Medxl Inc

Primary DI Number: 10682686004489
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259901445 *Terms of Use

Device Description: 3 mL of 0.9% Sodium Chloride Injection USP in a 5 mL syringe

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?
64786	Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial	A solution (e.g., saline, sterile water) intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an anticoagulant or antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGT	Saline, Vascular Access Flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171109	000

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3 mL fill in 5 mL syringe
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: 9bf4b00a-5cab-4b73-8f7a-8b2a25df9151
Public Version Date: May 07, 2024
Public Version Number: 4
DI Record Publish Date: March 19, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30682686004483	6	20682686004486		In Commercial Distribution	Carton
20682686004486	120	10682686004489		In Commercial Distribution	Case

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: +1.514.695.7474
Email: sales@medxl.com

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