AccessGUDID - DEVICE: Clear-View Multi-site Subcutaneous Infusion Set (M991SCIG53133AM1)

GUDID

Device Identifier (DI) Information

Brand Name: Clear-View Multi-site Subcutaneous Infusion Set
Version or Model: ClearView™MS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCIG53133AM
Company Name: NORFOLK MEDICAL

Primary DI Number: M991SCIG53133AM1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013861471 *Terms of Use

Device Description: 27G x 6mm x 36" Clear-View Multi-site "Sub-Q" Infusion Set w/ Male-to-Male Adapter (2 Sites)

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?
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K870188	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 27 Gauge

Device Record Status

Public Device Record Key: e86c71d1-dabc-4e8b-99a6-902ba143c309
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016