AccessGUDID - DEVICE: SITE-SCRUB (10801741086943)

GUDID

Device Identifier (DI) Information

Brand Name: SITE-SCRUB
Version or Model: 3882100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bard Access Systems, Inc.

Primary DI Number: 10801741086943
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: Site-ScrubTM IPA Device

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?
65043	Intravenous line connector disinfection scrubber	A hand-held device intended to be used to manually disinfect an in-line connector of an intravenous line (e.g., catheter injection port, needleless valve, Luer access valve) with scrubbing to reduce the risk of infection between intravenous administrations. It is in the form of a synthetic polymer cup containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant, and is operated by performing a twisting action over the connector for a few seconds. This device is not designed with a Luer-specific format and is not intended to remain in place after disinfection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKB	Pad, alcohol, device disinfectant

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: e379f175-e856-4b57-b5bd-c0d6329e6fa6
Public Version Date: December 21, 2023
Public Version Number: 1
DI Record Publish Date: December 13, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00801741086946 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

[?]

No Customer Contact currently defined

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