AccessGUDID - DEVICE: Excelsior (10363807500553)

GUDID

Device Identifier (DI) Information

Brand Name: Excelsior
Version or Model: E0500-55
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E0500-55
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10363807500553
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: Heparin Lock Flush, USP

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?
47132	Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial	A solution which contains a low dose (e.g., 10 i.u. ) of an anticoagulant agent(s) [typically heparin] 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 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
NZW	Heparin, vascular access flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133446	000

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
Special Storage Condition, Specify: Protect from freezing
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter
Device Size Text, specify: 50 USP Units per 5 mL (10 USP Units per mL) 5 mL fill in 10 mL flush syringe

Device Record Status

Public Device Record Key: 7cfd954a-2ba0-43b0-9697-1c5ed47dda0b
Public Version Date: July 07, 2020
Public Version Number: 5
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
20363807500550	6	10363807500553		In Commercial Distribution	case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00363807500556 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-5463
Email: service@medline.com

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