AccessGUDID - DEVICE: OPTFlow (00817708022285)

GUDID

Device Identifier (DI) Information

Brand Name: OPTFlow
Version or Model: OPT42612
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OPT42612
Company Name: EMED TECHNOLOGIES CORPORATION

Primary DI Number: 00817708022285
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 622637544 *Terms of Use

Device Description: OPTFlow SUB-Q 4 Needle set, 26ga RW x 12mm, 70cm Tubing with safety mechanism

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?
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: 4 Needles
Needle Gauge: 26 Gauge
Length: 12 Millimeter
Length: 70 Centimeter
Total Volume: 1.0 Milliliter

Device Record Status

Public Device Record Key: 5d2709a9-58ff-46b2-b23b-3370684712a4
Public Version Date: April 03, 2024
Public Version Number: 5
DI Record Publish Date: March 21, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00817708022278 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 916-932-0071
Email: customerservice@emedtc.com

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