AccessGUDID - DEVICE: BBN (06973980780122)

GUDID

Device Identifier (DI) Information

Brand Name: BBN
Version or Model: MI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JIAXING ZHENGQUN MEDICAL DEVICES CO.,LTD

Primary DI Number: 06973980780122
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529915664 *Terms of Use

Device Description: Disposable Medical Isolation Gown

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:	Yes
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?
58390	Visitor hygiene coverall	A garment intended to be worn by a visitor, or staff, in a healthcare facility as temporary clean clothing when with patients in non-sterile environments that may require a higher level of hygiene than a normal patient ward [e.g., intensive care unit (ICU), postoperative recovery ward]. Also known as a jump suit, it is a one-piece suit (overall) with sleeves, trouser legs, and fasteners intended to be worn over existing clothing to provide a barrier to help prevent cross-contamination of infectious agents between visitor and patients. This is a single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEA	Non-Surgical Isolation Gown

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: 7431e1e9-0c7f-49ee-a418-07190f3b26a2
Public Version Date: August 19, 2021
Public Version Number: 1
DI Record Publish Date: August 11, 2021

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: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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