AccessGUDID - DEVICE: Motion Medical Distributing (15060498451526)

GUDID

Device Identifier (DI) Information

Brand Name: Motion Medical Distributing
Version or Model: IN-202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IN-202
Company Name: Haslam Medical, Inc.

Primary DI Number: 15060498451526
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 604208868 *Terms of Use

Device Description: #IN-201 Infection Control Kit XL Contents: (1) Isolation Gown, (1) Sanifold N95 Mask, (1) Safety Glasses, (2) Glove Supreno, (1) Biohazard Bag 24x24, (2) Twist Tie, (2) Towel 3-Ply, (2) Sani-Hands Prep Pad

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?
61938	Surgical/examination garment kit	A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OKH	Body Fluids Barrier 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: 9133d050-dc3b-42ef-a5a4-ad232d58170d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 06, 2017