AccessGUDID - DEVICE: C2000 starter kit (04048675040958)

GUDID

Device Identifier (DI) Information

Brand Name: C2000 starter kit
Version or Model: MP01427
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drägerwerk AG & Co. KGaA

Primary DI Number: 04048675040958
Issuing Agency: GS1
Commercial Distribution End Date: April 04, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 315578914 *Terms of Use

Device Description: No description.

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?
10415	Bed blanket, reusable	A large piece of fabric or fabric-like material used to cover a patient/person to insulate body heat for warmth. It is typically used as a bed covering, but may be used for other purposes (e.g., as a wrap for warmth and comfort). The device is laundered for cleaning between periods of use. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, Skin Pressure

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: c5c07272-cd44-4681-8e3f-c75a962568bf
Public Version Date: July 25, 2023
Public Version Number: 3
DI Record Publish Date: October 24, 2015