AccessGUDID - DEVICE: ambIT* PIB-PCA v1.5 System w/Spike Filter Cass (00193494001308)

GUDID

Device Identifier (DI) Information

Brand Name: ambIT* PIB-PCA v1.5 System w/Spike Filter Cass
Version or Model: 220574
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 220574
Company Name: Avanos Medical, Inc.

Primary DI Number: 00193494001308
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: ambIT* PIB-PCA v1.5 System w/Spike Filter Cass

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?
46383	Peripheral anaesthesia catheter set, non-medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, infusion
MEA	Pump, infusion, pca

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162165	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 02ee7d38-fd00-4eb0-a04e-45c673d57957
Public Version Date: March 07, 2024
Public Version Number: 2
DI Record Publish Date: November 04, 2022