AccessGUDID - DEVICE: Apex (00076855700235)

GUDID

Device Identifier (DI) Information

Brand Name: Apex
Version or Model: 70023
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00076855700235
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: Oral Syrine With Adaptor

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
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?
36279	Medication cartridge syringe, needleless, single-use	A sterile device designed to be used in conjunction with a hermetically-sealed glass cartridge containing medication (not included) to propel the contents of the cartridge across the skin (transcutaneous delivery) and into the subcutaneous tissue (needleless) when used in combination with an injector (not included). It consists of a breech-loading barrel, plunger and specialized nozzle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYW	Container, Liquid Medication, Graduated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 1a046b68-ad23-4f66-ba31-c1b7e5b1f4ad
Public Version Date: September 04, 2023
Public Version Number: 2
DI Record Publish Date: January 08, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30076855700236	144	00076855700235		In Commercial Distribution

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: 800-376-7263
Email: customerservice@compasshealthbrands.com

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