AccessGUDID - DEVICE: Black & Black Surgical (00840329831646)

GUDID

Device Identifier (DI) Information

Brand Name: Black & Black Surgical
Version or Model: B89HCC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B89HCC
Company Name: BLACK & BLACK SURGICAL, INC.

Primary DI Number: 00840329831646
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004382282 *Terms of Use

Device Description: HAND CRANK CENTRIFUGE, 60CC SYRINGES, TABLE MOUNT WITH SYRINGE RACK

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:	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?
62648	Blood component separator, manual	A manually-operated device designed for the separation of previously centrifuged blood into components [e.g., red blood cells (RBCs), plasma, platelets] for further processing or storage. It is a compact mechanical unit (non-powered) that uses pressure plates to facilitate the transfer of each component from the donor bag into a respective collection bag. It is typically used in a blood bank or transfusion centre, and is not donor or patient connected.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: d1e40c94-66cd-4434-8643-bbe31c28c612
Public Version Date: May 29, 2023
Public Version Number: 1
DI Record Publish Date: May 19, 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
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

[?]

Phone: +1(770)414-4880
Email: info@blackandblacksurgical.com

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

FDA TOOLS & RESOURCES