AccessGUDID - DEVICE: V. Mueller (10885403133893)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: 006.07
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 006.07
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403133893
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: C-ARM DRAPE 27 X 17 X 77IN 10/BX

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
12535	Medical equipment/instrument drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMW	Drape, microscope, ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K902851	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: d8c6ea56-81fa-4742-ad6e-598accc58a51
Public Version Date: September 11, 2024
Public Version Number: 7
DI Record Publish Date: October 17, 2017