DEVICE: 212NY (G33527000L1)
Device Identifier (DI) Information
212NY
27000
In Commercial Distribution
27000
Two One Two New York, Inc.
27000
In Commercial Distribution
27000
Two One Two New York, Inc.
IIJA COMPLIANT DISPOSABLE ISOLATION GOWN LEVEL 2 ANSI/AAMI - SIZE LARGE 10 PACK
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35492 | Isolation gown, single-use |
A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OEA | Non-Surgical Isolation Gown |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
360134d7-cf9a-4f22-966b-ccb8b5d22f5d
November 22, 2022
1
November 14, 2022
November 22, 2022
1
November 14, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
G33527000L2 | 10 | G33527000L1 | In Commercial Distribution | CARTON |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
G33527000L0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
2128408665
health@212nyusa.com
health@212nyusa.com