AccessGUDID - DEVICE: SeromaCath (00854373007056)

GUDID

Device Identifier (DI) Information

Brand Name: SeromaCath
Version or Model: 1275 Pouch
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1275
Company Name: GREER MEDICAL, INC.

Primary DI Number: 00854373007056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800169260 *Terms of Use

Device Description: Blunt SeromaCath Wound Drainage System 14G (2,1mm) x 2" (5cm)

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:	Yes
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?
11305	Closed-wound drain, non-bioabsorbable	A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K905733	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
Handling Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 33 and 105 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Inch
Device Size Text, specify: Catheter Gauge: 14: Gauge

Device Record Status

Public Device Record Key: b5078364-5e83-4083-b74e-084c0ab15889
Public Version Date: March 08, 2022
Public Version Number: 4
DI Record Publish Date: May 10, 2017

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

Customer Contact

[?]

Phone: 805-962-5883
Email: info@greer-medical.com

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