AccessGUDID - DEVICE: Motion Medical Distributing (15060498450192)

GUDID

Device Identifier (DI) Information

Brand Name: Motion Medical Distributing
Version or Model: 1681
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1681
Company Name: Haslam Medical, Inc.

Primary DI Number: 15060498450192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 604208868 *Terms of Use

Device Description: #1681 Chest Decompression Kit Contents: (4) PVP Swabstick Single, (3) Sponge 4x4 2/Pk, (4) Gloves L/F, (2) Syringe 20cc, (4) Catheter 14Gx2", (2) Stop Cock

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
47200	Pneumothorax catheter insertion set	A collection of devices used to puncture the chest wall to enable insertion of a dedicated catheter for the aspiration of a simple pneumothorax or decompression of a tension pneumothorax. It typically consists of a scalpel to make a stab incision and a needle to assist the entry of the catheter with obturator assembly (to protect the internal organs upon entry). Once the catheter is in place, the needle is retracted to allow the flow of air/fluid from within the chest cavity. The set may contain suture for the attachment of the catheter to the skin. It is typically used for accident and emergency (A&E) situations (immediate care or chest crush injury). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWL	Peripheral Catheter Insertion Kit

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: 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: 239c729b-30b9-47b4-9795-bb19cbc4c75b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 06, 2016