AccessGUDID - DEVICE: Atlanta Healthcare Services OcuDrape® (10851736007705)

GUDID

Device Identifier (DI) Information

Brand Name: Atlanta Healthcare Services OcuDrape®
Version or Model: 10851736007705
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AHS550NS
Company Name: ATLANTA HEALTHCARE SERVICES, INC.

Primary DI Number: 10851736007705
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 130599421 *Terms of Use

Device Description: Fluid Pouch 500cc 12" wide x 7" deep, 12" x 1-1/2" adhesive tape, forming bar

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?
58982	Surgical tissue/fluid collection bag, non-sterile	A non-sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HMT	Drape, patient, ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K854613	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 7 Inch
Width: 12 Inch

Device Record Status

Public Device Record Key: f0acebc4-af1a-4bc2-860f-9db0f8f6a7eb
Public Version Date: August 31, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2016