AccessGUDID - DEVICE: 28A Roll In Cot (00190790001087)

GUDID

Device Identifier (DI) Information

Brand Name: 28A Roll In Cot
Version or Model: 0063099
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FERNO-WASHINGTON, INC.

Primary DI Number: 00190790001087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004239034 *Terms of Use

Device Description: 28A Roll In Cot, Aero

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?
35843	Ambulance stretcher, manual	A manually-operated device consisting of a platform mounted on a wheeled frame designed for use by emergency medical services (EMS) primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles (e.g., automobiles, aeroplanes, helicopters, boats); it does not include a powered or powered-assisted lifting mechanism. It is typically constructed of lightweight materials and has an undercarriage that opens and folds when it is removed from or pushed into the ambulance; it also usually includes locking devices that match with the locking/docking devices in the ambulance.	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: 3b52f1da-2b2a-48a4-b369-3d03e7731ac7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 22, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 937-283-2950
Email: complaintcoordinator@ferno.com

Phone: 937-382-1685
Email: tscoordinator@ferno.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES