AccessGUDID - DEVICE: ALLCARE (10182921000684)

GUDID

Device Identifier (DI) Information

Brand Name: ALLCARE
Version or Model: EB500B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EB500B
Company Name: ALLCARE, INC

Primary DI Number: 10182921000684
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 362187580 *Terms of Use

Device Description: FLEECE BLANKET BLUE 60" X 90", 10/Case

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f120c82c-f043-474d-b58e-8e6b1edae7c2
Public Version Date: December 05, 2022
Public Version Number: 1
DI Record Publish Date: November 27, 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: 00182921000687 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 630.830.7486
Email: qra@allcaredirect.com

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