SUB-Q - 36" Single SUB-Q set, 12mm needle and 27-gauge - EMED TECHNOLOGIES CORPORATION

Duns Number:622637544

Device Description: 36" Single SUB-Q set, 12mm needle and 27-gauge w/Dressing, Box of 10

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More Product Details

Catalog Number

SUB-112-G27-Q10

Brand Name

SUB-Q

Version/Model Number

SUB-112-G27-Q10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140131,K140131

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

e75b876a-5a14-4fac-b7eb-9fbc2cf02dd8

Public Version Date

December 15, 2020

Public Version Number

1

DI Record Publish Date

December 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EMED TECHNOLOGIES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26