AccessGUDID - DEVICE: Bioseal Inc. (00630094193939)

GUDID

Device Identifier (DI) Information

Brand Name: Bioseal Inc.
Version or Model: 19393/12
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOSEAL

Primary DI Number: 00630094193939
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 186968939 *Terms of Use

Device Description: Bed Sheet Hyperbaric

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?
47447	Bed blanket, single-use	A large piece of fabric or fabric-like material used to cover a patient/person to insulate body heat for warmth. It is typically used as a bed covering, but may be used for other purposes (e.g., as a wrap for warmth and comfort). This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KME	BEDDING, DISPOSABLE, MEDICAL

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: Yes
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: 1e403782-f0ac-4e31-91cd-c40638dbb5e9
Public Version Date: October 18, 2023
Public Version Number: 1
DI Record Publish Date: October 10, 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
10630094193936	12	00630094193939		In Commercial Distribution	Case

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: Yes
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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