AccessGUDID - DEVICE: Startup Package,7 Items (00840314806451)

GUDID

Device Identifier (DI) Information

Brand Name: Startup Package,7 Items
Version or Model: 8955
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hausmann Enterprises, LLC

Primary DI Number: 00840314806451
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001892660 *Terms of Use

Device Description: No description.

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):	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?
40602	Chest-press exerciser	A mechanical exercise apparatus primarily intended to strengthen the muscles of the chest (especially the pectoralis major) through a repetitive pushing or pulling motion performed with the arms against the force of a weight. It typically consists of a metal frame containing a lever or pulley-cable system that incorporates changeable weights and bars and/or handles/hand stirrups for the user to grip and push or pull; also typically included is a bench for the user to sit or lay while performing the exercise (some exercises referred to as bench press). The device may also be used to help strengthen other upper-body muscles (e.g., deltoids, biceps, triceps).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOD	Components, Exercise

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: b7b9c1ea-7ccf-4a61-981f-60001203c1ff
Public Version Date: August 24, 2022
Public Version Number: 1
DI Record Publish Date: August 16, 2022

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

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES