AccessGUDID - DEVICE: Envella™ Bed (00887761013834)

GUDID

Device Identifier (DI) Information

Brand Name: Envella™ Bed
Version or Model: P0819A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HILL-ROM, INC.

Primary DI Number: 00887761013834
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004245668 *Terms of Use

Device Description: Hospital Bed

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
35921	Air-fluidized bed	A mains electricity (AC-powered) bed designed for the treatment of severely and extensively burned patients. It may also be used in cases of decubitus ulcers or where the patient has little remaining body fat (extreme anorexia) and the displacement of the body weight is vital. It employs the circulation of filtered and temperature-regulated air forced through large quantities of ceramic spherules (small round beads) which become transformed from a solid mass into an almost liquid (fluidized) state, providing the patient with complete uplift over the whole supine body surface. Other beneficial effects are the drying of wound seepage and reduction of infection risk.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INX	BED, AIR FLUIDIZED

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: fe85a4e0-386d-45f6-8664-dd37b65ab934
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 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: +1(800)445-3730
Email: us.customerservice@hill-rom.com

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