AccessGUDID - DEVICE: NA (00085412624822)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: ADS201815
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ADS201815
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 00085412624822
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: DISPOSABLE CURVED APPLICATOR

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?
47186	Haematological concentrate/haemostatic agent applicator	A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYZ	SYRINGE, IRRIGATING (NON DENTAL)

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store between 2 degrees Celsius to 25 degrees Celsius, 36 degrees Fahrenheit to 77 degrees Fahrenheit. Store in original packaging. Keep away from sunlight and excessive heat.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 Centimeter x 10 Gauge

Device Record Status

Public Device Record Key: 0c49ac77-9660-4db1-9f34-44abdfcdd88d
Public Version Date: November 03, 2022
Public Version Number: 6
DI Record Publish Date: January 03, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20085412624826	10	00085412624822		In Commercial Distribution	PACK_OR_INNER_PACK
50085412624827	24	20085412624826		In Commercial Distribution	CA

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

[?]

Phone: +1(888)229-0001
Email: MEDINFO_MEDPRODUCTS@BAXTER.COM

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