AccessGUDID - DEVICE: SCIg60 (00817708023398)

GUDID

Device Identifier (DI) Information

Brand Name: SCIg60
Version or Model: FP-0010032
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EMED TECHNOLOGIES CORPORATION

Primary DI Number: 00817708023398
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622637544 *Terms of Use

Device Description: SCIg60 Infusion Pump Carrying Case

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:	No
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?
46845	Ambulatory non-insulin infusion pump, mechanical, reusable	A non-electric, mechanically-powered (e.g., a spring mechanism) device designed for the continuous or intermittent infusion of medication, typically for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA) by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It is primarily designed to be worn by the patient during ambulation in the home. It may include flow and fluid level mechanical indicators and may be worn by the patient within and outside healthcare settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PKP	Immunoglobulin G (Igg) Infusion System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142319	000
K161906	000
K173783	000
K222087	000
K240148	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: 42c58d71-3aca-498d-9518-7f9ea4ade3ab
Public Version Date: January 14, 2025
Public Version Number: 5
DI Record Publish Date: August 07, 2020

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: No Unit of Use DI Numbers Found 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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