AccessGUDID - DEVICE: Medline (10817357022220)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: MDS9911HP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HYGIA HEALTH SERVICES, INC.

Primary DI Number: 10817357022220
Issuing Agency: GS1
Commercial Distribution End Date: February 21, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 177939027 *Terms of Use

Device Description: MEDLINE CUFF, BP, DIS, 1T, CHI, HP

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:	Yes
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?
61801	Blood pressure cuff, reprocessed	A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) intended to be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NPP	Reprocessed Blood Pressure Cuff

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032821	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: 82f75d08-1740-45d8-864b-3fe10bf395db
Public Version Date: March 19, 2021
Public Version Number: 4
DI Record Publish Date: February 04, 2017