AccessGUDID - DEVICE: SAF-Q (00817708022889)

GUDID

Device Identifier (DI) Information

Brand Name: SAF-Q
Version or Model: SAF-Q-206-G24-70
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SAF-Q-206-G24-70
Company Name: EMED TECHNOLOGIES CORPORATION

Primary DI Number: 00817708022889
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 622637544 *Terms of Use

Device Description: Bi-furcated SUB-Q set with safety, 24-gauge x 6mm needle, 70cm tubing w/dressing

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):	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?
46846	Mechanical infusion pump administration set	A collection of devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication (not included), typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. 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 [?]
K140131	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
Storage Environment Temperature: between -5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2 Needles
Needle Gauge: 24 Gauge
Length: 6 Millimeter
Length: 70 Centimeter
Total Volume: 0.52 Milliliter

Device Record Status

Public Device Record Key: 077709ca-0af7-488c-8e99-848c6b624498
Public Version Date: April 03, 2024
Public Version Number: 6
DI Record Publish Date: December 12, 2017