AccessGUDID - DEVICE: E1972CLT (00850925007635)

GUDID

Device Identifier (DI) Information

Brand Name: E1972CLT
Version or Model: E1972CLT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E1972CLT
Company Name: NOVUM MEDICAL PRODUCTS INC

Primary DI Number: 00850925007635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066412472 *Terms of Use

Device Description: Infant Series Crib, Klimer, 2 Side Drop, Trendelenburg Deck, Confetti Powder Coat

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?
37010	Paediatric bed	A bed with appropriate size for children (typically up to 12 years of age) that incorporates safety canopy tops, fixed endrails, and moveable and latchable siderails. It allows children complete freedom in bed without the danger of falling out, yet allows staff access to the patient. Paediatric beds are not appropriate for neonates/infants.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMS	Bed, Pediatric Open Hospital

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: 28a6b5c5-2224-4fb4-842a-6af168a52455
Public Version Date: May 14, 2018
Public Version Number: 1
DI Record Publish Date: April 13, 2018