MEIJER, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pack, Hot Or Cold, Reuseable (IME) (5) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (2) Floss, Dental (JES) (1) Lubricant, Patient (KMJ) (1) Toothbrush, Powered (JEQ) (1)

Premarket Exempt

No Yes

Clear

Meijer - 00708820494664 Catalog Number :

Device Description : 100yd mint Tape Floss

Device Class : 1

Duns Number: 006959555

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 1

Meijer Vaginal Moisturizer Personal Lubricant - 00708820514591 Catalog Number :

Device Description : Prefilled Disposable Personal Lubricant Applicator

Device Class : 1

Duns Number: 006959555

Premarket Exempt : No

Product Code : KMJ

Prescription Use : No

Device Count : 1

Meijer - 00708820514935 Catalog Number : 74-5502

Device Description : Meijer Aneroid Self-Taking Home BP Kit

Device Class : 2

Duns Number: 006959555

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Meijer Hot/Cold Back Pad - 00708820519541 Catalog Number :

Device Description : 13" x 12" (33 cm x 30.5 cm) back pad utilizes hot & cold therapy to relieve pain 13" x 12" (33 cm x 30.5 cm) back pad utilizes hot & cold therapy to relieve pain, reduce swelling, relax tight back muscles, and increase circulation.

Device Class : 1

Duns Number: 006959555

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Meijer Hot & Cold Wrap Ultra-Forming - 00708820519558 Catalog Number :

Device Description : 6" x 15.5" (15.24 cm x 39.37 cm) hot and cold ultra-forming & reusable therapy w 6" x 15.5" (15.24 cm x 39.37 cm) hot and cold ultra-forming & reusable therapy wrap provides relief to minor muscle aches and pains.

Device Class : 1

Duns Number: 006959555

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Meijer Hot & Cold Therapy Wrap with Clay Based Technology - 00708820523418 Catalog Number :

Device Description : 6" x 12" (15.24 cm x 30.48 cm) clay pack used along with soft cover equipped wit 6" x 12" (15.24 cm x 30.48 cm) clay pack used along with soft cover equipped with elastic strap to relieve sore muscles, stiff muscles and joints, head and back aches, cramps and athletic injuries.

Device Class : 1

Duns Number: 006959555

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Meijer Hot & Cold Beads Compress with Strap - 00708820523425 Catalog Number :

Device Description : 7.5" x 4.5" (19.1 cm x 11.4 cm) pack with elastic strap that is reusable and rel 7.5" x 4.5" (19.1 cm x 11.4 cm) pack with elastic strap that is reusable and relieves sore muscles, sprains, and swelling.

Device Class : 1

Duns Number: 006959555

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Meijer Moist Heat Neck Wrap - 00708820523432 Catalog Number :

Device Description : 19" x 7" (45.7 cm x 17.8 cm) hot & cold therapy neck wrap with elastic strap to 19" x 7" (45.7 cm x 17.8 cm) hot & cold therapy neck wrap with elastic strap to relieve pain, stiffness, and tension.

Device Class : 1

Duns Number: 006959555

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Meijer - 00708820575394 Catalog Number : 74-523

Device Description : Meijer Blood Pressure Monitor Automatic Wrist

Device Class :

Duns Number: 006959555

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Meijer - 00708820630338 Catalog Number :

Device Description : Polaris II Power Toothbrush soft

Device Class : 1

Duns Number: 006959555

Premarket Exempt : Yes

Product Code : JEQ

Prescription Use : No

Device Count : 2

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