AccessGUDID - DEVICE: BRAT 2 (08033178106153)

GUDID

Device Identifier (DI) Information

Brand Name: BRAT 2
Version or Model: OUTLET CLAMP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SORIN GROUP ITALIA SRL

Primary DI Number: 08033178106153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 442126587 *Terms of Use

Device Description: No description.

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):	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?
42924	Blood autotransfusion system tubing	A sterile length of flexible tube, typically made of synthetic polymer material(s), intended to be used in a blood autotransfusion system typically as an extension to channel blood between the bellows and the autotransfusion bag. The tubing may be used to maintain a closed-circuit during blood collection and reinfusion. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CAC	APPARATUS, AUTOTRANSFUSION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K974897	000

Device Exempt from Premarket Submission: No 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: b2bce0f6-3656-464e-b4f4-1206bb563bc7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 06, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
38033178106154	144	18033178106150		In Commercial Distribution	BOX
18033178106150	12	08033178106153		In Commercial Distribution	BOX

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

Customer Contact

[?]

No Customer Contact currently defined

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