AccessGUDID - DEVICE: COMPLETE TRANSPORT STRETCHER (B286PT1000311)

GUDID

Device Identifier (DI) Information

Brand Name: COMPLETE TRANSPORT STRETCHER
Version or Model: PT1000-31
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PT1000-31
Company Name: M.A.C. MEDICAL INC.

Primary DI Number: B286PT1000311
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188660844 *Terms of Use

Device Description: MOBILECARE STRETCHER WITH PNEUMATIC BACK ADJUSTMENT. CLEARLY MARKED HEIGHT ADJUST PEDALS ON BOTH SIDES WITH RANGE OF 23" TO 36". TRENDELENBURG AND REVERSE TRENDELEBURG ADJUSTMENT PEDALS ON BOTH SIDES. FOLD DOWN SIDE RAILS. BUILT IN O2 CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDAL AT EACH CORNER. I.V. POLE AND 4" FOAM MATTRESS INCLUDED. WEIGHT CAPACITY 550LB. BED SURFACE 31" X 77"

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:	No
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?
35892	Hospital stretcher, manual	A manually-operated device consisting of a platform mounted on a wheeled frame designed primarily to facilitate easy transport of a recumbent patient within a healthcare facility; it may include side rails, supports for fluid infusion equipment, and patient securement straps. The device may also be used as a treatment table (e.g., in an emergency, recovery, or labour room), or as a bed in some intensive and specialized care units or under high patient census conditions (e.g., disasters).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPO	Stretcher, Wheeled

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: e15e311c-f2d2-4fe1-b26a-6821e5a6434a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 26, 2016