AccessGUDID - DEVICE: Instavac I (08688250002580)

GUDID

Device Identifier (DI) Information

Brand Name: Instavac I
Version or Model: Instavac I
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OHIO MEDICAL, LLC

Primary DI Number: 08688250002580
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 005192885 *Terms of Use

Device Description: Portable Suction Pump

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:	No
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?
63648	General-purpose surgical suction system, electric	A portable assembly of devices, which includes a surgically invasive component, intended to aspirate body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy, urological surgical procedure); it may in addition have non-surgical applications. It is typically intended to remove debris, tissues and fluids, to clear a site and facilitate observation. It includes an electrically-powered suction pump, collection containers, tubing, and patient contact devices (e.g., handpiece/tip, catheter); it is not designed for irrigation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTA	Pump, Portable, Aspiration (Manual Or Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K933902	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: aa988724-3bca-4f43-a1d0-eb1236a5152d
Public Version Date: April 30, 2020
Public Version Number: 5
DI Record Publish Date: January 05, 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18478550500
Email: customer.service@ohiomedical.com

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