FDA.report

E.M. Adams Co, Inc.

Primary DI
50840200322916
Brand
E.M. Adams Co, Inc.
Company
E.M. ADAMS, INC.
Model
EP90304S-1
Device description
SAFETY VEST
Published
2022-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FMQRestraint, Protective

Product Code Classifications

CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50840200322916PackageGS124In Commercial Distribution
10840200322925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5084020032291650840200322916
1084020032292510840200322925

GMDN Terms

TermDefinition
Limb/torso/head restraint, reusableA non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
772-461-0532emadams@emadamsco.com

Regulatory Flags

DUNS number
001403807
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50840200325580E.M. Adams Co Inc14-70809JK-12023-11-21
50840200325566E.M. Adams Co, Inc114-A3609-12023-11-17
50840200301072E.M. Adams Co Inc114-A11341-12023-10-31
10840200325551E.M. Adams Co Inc114-31613-12023-10-31
50840200325528E.M. Adams Co, Inc.14-3497-12023-10-20
50840200325443E.M. Adams co, inc.EP30405L-12023-06-20
50840200325313E.M. Adams Company14-3390-12022-08-18
50840200313525E.M. ADAMS CO, INC26-0615XL-12022-07-17
50840200313549E.M. ADAMS CO, INC26-0615XXL-12022-07-17
50840200313563E.M. ADAMS CO, INC26-0615XXXL-12022-07-17
50840200313587E.M. ADAMS CO, INC26-0615XXXXL-12022-07-17
50840200313624E.M. ADAMS CO, INC26-0644-12022-07-17
50840200313648E.M. ADAMS CO, INC26-0654-12022-07-17
50840200314744E.M. ADAMS CO, INCEP28-30205B-12022-07-17
50840200314768E.M. ADAMS CO, INCEP28-30205G-12022-07-17
50840200314782E.M. ADAMS CO, INCEP28-30205U-12022-07-17
50840200314805E.M. ADAMS CO, INCEP28-30206B-12022-07-17
50840200314843E.M. ADAMS CO, INCEP28-30206U-12022-07-17
50840200314867E.M. ADAMS CO, INCEP28-30207B-12022-07-17
50840200314881E.M. ADAMS CO, INCEP28-30207G-12022-07-17

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