IMCO

GUDID 20815842023162

Facemask, Earloop, Economy, Yellow

INDEPENDENT MEDICAL CO-OP, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 20815842023162
• NIH Device Record Key: dcfd7bd8-1722-4770-b8ee-203a2215768c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMCO
• Version Model Number: 1531-IMC
• Company DUNS: 073436164
• Company Name: INDEPENDENT MEDICAL CO-OP, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815842023168 [Primary]
GS1	10815842023165 [Package]; Contains: 00815842023168; Package: Inner Pack [50 Units]; In Commercial Distribution
GS1	20815842023162 [Package]; Contains: 10815842023165; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051291

FDA Product Code

• FXX: Mask, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-06-20

On-Brand Devices [IMCO]

• 10815842023400: Woven Tape Measure
• 10815842023394: Standard Bulb and Valve, LF
• 20815842023179: Sterilization Pouch, SS, 12" x 15"
• 20815842023162: Facemask, Earloop, Economy, Yellow
• 20815842023155: Facemask, Earloop, Economy, Blue
• 20815842023148: Sterilization Pouch, SS, 5 1/4" x 10"
• 20815842023131: Sterilization Pouch, SS, 3 1/2" x 9"
• 20815842023124: Sterilization Pouch, SS, 7 1/2" x 13"
• 20815842023117: Sterilization Pouch, SS, 3 1/2"x 6 1/2"
• 10815842023103: Standard Bulb and Valve
• 10815842023097: Cuff and Bladder, 2 Tube, Large Adult
• 10815842023080: Cuff and Bladder, 2 Tube, Adult
• 10815842023073: Cuff and Bladder, 2 Tube, Small Adult
• 10815842023066: Gauge for Premium and Standard Aneroid
• 10815842023059: Aneroid Sphygmomanometer, Value Line, Adult
• 10815842023042: Aneroid Sphygmomanometer, Value Line, Large Adult
• 10815842023035: Aneroid Sphygmomanometer, Value Line, Child
• 10815842023028: Aneroid Sphygmomanometer, Basic, Large Adult
• 10815842023011: Aneroid Sphygmomanometer, Basic, Small Adult
• 10815842023004: Aneroid Sphygmomanometer, Basic, Adult
• 10815842022991: Aneroid Sphygmomanometer, Standard, Large Adult
• 10815842022984: Aneroid Sphygmomanometer, Standard, Adult
• 10815842022977: Aneroid Sphygmomanometer, Standard, Small Adult
• 10815842022960: Aneroid Sphygmomanometer, Premium, Large Adult
• 00815842022956: Aneroid Sphygmomanometer, Premium, Small Adult
• 10815842022946: Aneroid Sphygmomanometer, Premium, Adult
• 10815842021604: Polyglycolic Suture, 4-0, C3 Needle
• 10815842021598: Poluglycolic Suture, 5-0, C3 Needle
• 10815842021581: Polyglycolic Suture, 4-0, C6 Needle
• 10815842021574: Polypropylene Suture, 4-0, C3 Needle
• 10815842021567: Polypropylene Suture, 5-0, C3 Needle
• 10815842021550: Polypropylene Suture, 6-0, C1 Needle
• 10815842021543: Polypropylene Suture, 4-0, C6 Needle
• 10815842021536: Nylon Suture, 4-0, C3 Needle
• 10815842021529: Nylon Suture, 5-0, C-3 Needle
• 10815842021512: Nylon Suture, 6-0, C1 Needle
• 10815842021505: Nylon Suture, 3-0, C7 Needle
• 10815842021499: Nylon Sutuer, 4-0, C6 Needle
• 10815842021482: Nylon Suture, 5-0, C6 Needle
• 10815842021475: Nylon Suture, 6-0, C3 Needle
• 00815842021461: Nylon Suture, 4-0, PC 31 Needle