AccessGUDID - DEVICE: BRYDAN MEDICAL (00863574000483)

GUDID

Device Identifier (DI) Information

Brand Name: BRYDAN MEDICAL
Version or Model: 11459
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BRYDAN MEDICAL HOLDINGS

Primary DI Number: 00863574000483
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078612438 *Terms of Use

Device Description: Alum W/C 20" seat width, green uph.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
38803	Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible	A wheeled personal mobility device that incorporates a heavy-duty framework and extra wide seat-support system for a bariatric (obese) person with a disability or an obese person without the full capacity to walk, and is manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device cannot be folded or readily dismantled for transport.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IOR	Wheelchair, Mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973418	000

Device Exempt from Premarket Submission: No 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: 888611b8-d3bb-4a96-9e9d-1371b36d283f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 03, 2018

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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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