AccessGUDID - DEVICE: SPIKE ADAPTER (04046964183454)

GUDID

Device Identifier (DI) Information

Brand Name: SPIKE ADAPTER
Version or Model: 418121
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 418121
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964183454
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: PINNACLE® Vented Micro Spike Adapter

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):	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?
64997	Non-ISO80369 formatted bag access spike	A small, noninvasive, tubular connector with a small-bore connection/port, none of which is designed according to ISO 80369 (non-ISO80369 formatted), and a hollow bag-access spike (either blunt or sharp) intended to connect an intravenous (IV) fluid or blood bag to a fluid line for administration to a patient. It may include a built-in air filter and drip chamber; it does not include tubing (i.e., not a tubing set) or any Luer formatted connections. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 7291dc9c-1f1b-4bad-b94c-f1969f833938
Public Version Date: November 06, 2020
Public Version Number: 6
DI Record Publish Date: September 23, 2016

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: 04046964183447 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

[?]

Phone: +1(800)227-2862
Email: BBMUS_Service.EmailOrders@bbraun.com

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