AccessGUDID - DEVICE: Right Way Medical (00860001018806)

GUDID

Device Identifier (DI) Information

Brand Name: Right Way Medical
Version or Model: RTPN1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: RIGHT WAY MEDICAL LLC

Primary DI Number: 00860001018806
Issuing Agency: GS1
Commercial Distribution End Date: November 19, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 006811886 *Terms of Use

Device Description: EVA TPN BAG FOR PARENTERAL NUTRITION 1000ML

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?
46846	Mechanical infusion pump administration set	A collection of devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication (not included), typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPE	Container, I.V.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 863c6438-454a-44a0-b002-3a1e07c8a869
Public Version Date: April 03, 2024
Public Version Number: 3
DI Record Publish Date: April 01, 2019