AccessGUDID - DEVICE: Excelsior (10363807103358)

GUDID

Device Identifier (DI) Information

Brand Name: Excelsior
Version or Model: E0103-35
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E0103-35
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10363807103358
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: SwabFlush®

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?
61142	Vascular access device flush/disinfection tool	A manual device intended to be used to flush wash the lumen of an in situ vascular access device (e.g., catheter, needleless intravenous line) and to disinfect the device’s Luer access valve. It consists of a prefilled syringe containing a saline solution, and a disinfection cap or scrubber containing a foam material saturated with disinfectant [e.g., isopropyl alcohol (IPA)]. It may be supplied as a one-piece or modular device. 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 [?]
K130975	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: Do not freeze
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3 mL fill in 10 mL flush syringe with integrated SwabCap®
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: 8f45ca52-dc80-4c10-9374-e3403a18198a
Public Version Date: September 16, 2022
Public Version Number: 4
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
20363807103355	8	10363807103358		In Commercial Distribution	case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00363807103351 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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