DEVICE: Haemonetics (10887691000673)

Device Identifier (DI) Information

Haemonetics
SQ40SK
In Commercial Distribution

HAEMONETICS CORPORATION
10887691000673
GS1

1
057827420 *Terms of Use
Microaggregate Blood Transfusion Filter with Attached Straight Administration Set with 3 mm Tubing
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Blood donor set, single-pack An assembly of sterile devices intended to be used to collect whole blood from a donor. It includes a container (a single flexible bag) with anticoagulation solution, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the blood is tested, stored, and infused from the container when needed. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CAK Microfilter, blood transfusion
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K960993 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

730b487d-92e9-4bd4-bbec-c0e7c6a02ddd
July 06, 2018
3
February 06, 2017
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30887691000677 16 10887691000673 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)-537-2802
pirdesk@Haemonetics.com
CLOSE