AccessGUDID - DEVICE: JEDMED (M6330358580)

GUDID

Device Identifier (DI) Information

Brand Name: JEDMED
Version or Model: 03-5858
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03-5858
Company Name: JEDMED INSTRUMENT COMPANY

Primary DI Number: M6330358580
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092987189 *Terms of Use

Device Description: Conversion Kit / Glass Trap F/ Spectrm

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?
38476	Suction system bottle	A cylindrical sealable container made of glass or plastic (typically chemical resistant) that is used as a component of a suction system, or other system that utilizes suction, for the collection of aspirated waste materials (e.g., blood, bodily fluids, laser plume evacuation gas) and/or body tissue intended for diagnostic/therapeutic purposes (e.g., histological analysis, autologous fat tissue transfer) from a site of operation. It may be used singularly or in a connected series to provide greater capacity, and may be calibrated to facilitate determination of the quantity of its contents. Suction system bottles are not used in conjunction with suction liners. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	Bottle, Collection, Vacuum

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: e4da1e96-6693-4692-bc33-66bccd8802c9
Public Version Date: August 13, 2018
Public Version Number: 1
DI Record Publish Date: July 13, 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: 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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 314-845-3770
Email: info@jedmed.com

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