AccessGUDID - DEVICE: NURSE ASSIST (B150516384)

GUDID

Device Identifier (DI) Information

Brand Name: NURSE ASSIST
Version or Model: 51638
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NURSE ASSIST, INC.

Primary DI Number: B150516384
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 400
Labeler D-U-N-S® Number*: 869434464 *Terms of Use

Device Description: 10ML PREFILLED 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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
44707	Device-irrigation sterile water	A fluid consisting of sterile water (H2O) that is used exclusively for the cleaning and irrigation of a device (e.g., a Foley catheter or a tracheobronchial suction catheter). It is not intended for wound irrigation or injection or intravenous (IV) administration. The device is usually available in a plastic container or bottle of various sizes. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZL	Catheter, Retention Type, Balloon

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030813	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e4317fe3-c2e2-4e53-ae17-f40440035ad3
Public Version Date: July 06, 2018
Public Version Number: 3
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
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: B150516380 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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